HCC - Hepatocellular CarcinomaNCT07001085
ctDNA Monitoring in Patients With HCC and mCRC
A study testing Tumor Tissue Collection and NGS, Blood Collection for Plasma ctDNA and ctDNA Mutation Analysis via ddPCR in people with HCC - Hepatocellular Carcinoma and Colorectal Cancer Metastatic, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
"Liquid biopsy" is a collective term that refers to the analysis of cancer-derived biomarkers isolated from the biological fluids of cancer patients. The analysis of these blood components can be used for early cancer detection, staging, prognosis, drug resistance monitoring, and minimal residual disease (MRD)… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- HCC - Hepatocellular Carcinoma, Colorectal Cancer Metastatic
- What is being tested?
- Tumor Tissue Collection and NGS, Blood Collection for Plasma ctDNA and ctDNA Mutation Analysis via ddPCR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jan 2025to 30 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18-75 years of both sexes;
- patients with synchronous or metachronous metastases of colorectal cancer limited to the liver after complete removal of the primary lesion from the intestine qualified for liver resection or transplantation;
- or patients with resectable or unresectable HCC scheduled for liver resection or transplantation
- no history of other cancers;
- negative virological status in the case of mCRC;
- In the case of mCRC - patient after any type of liver surgery (staged, ALPPS, multi-site resection)
- Patient with or without neoadjuvant chemotherapy compatible with established adjuvant therapy
Who cannot join
- age under 18 and over 75;
- pregnancy
- patients with extrahepatic metastases visible in imaging studies;
- metabolic and autoimmune diseases or chronic immunosuppressive treatment other than in the group of patients after liver transplantation due to HCC;
- positive virological status, excluding the group of patients with HCC;
- history of other cancer;
Show all 10Show fewer
- Chronic steroid therapy and diagnosed active autoimmune diseases
- Patient after radiotherapy
- Patient participating in other clinical trials of oncological and non-oncological drugs
- Patients legally incapacitated
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Medical University of Warsaw
Warsaw, Masovian Voivodeship, 02-091
About this study
Official title: A Prospective Randomized Trial Assessing the Impact of ctDNA Testing in Patients After Liver Resection or Transplantation Due to Metastases From Colorectal Cancer or Hepatocellular Carcinoma (HCC) on Treatment Strategies and Long-term Survival"
"Liquid biopsy" is a collective term that refers to the analysis of cancer-derived biomarkers isolated from the biological fluids of cancer patients. The analysis of these blood components can be used for early cancer detection, staging, prognosis, drug resistance monitoring, and minimal residual disease (MRD) monitoring. The "liquid biopsy" is based on the fact that cancer cells release their DNA into the bloodstream, known as ctDNA (circulating tumor DNA). A sample of the patient's peripheral blood is sufficient to test ctDNA. There have been many studies in the literature on the usefulness of liquid biopsy in the treatment of various malignancies, such as breast cancer, prostate cancer, and colorectal cancer. However, this has been a lack of prospectively obtained data analyzing the impact on the ctDNA assessment of the progression and recurrence of the primary disease or the type of treatment applied to improve long-term survival. The ctDNA test is not a widely recognized technology for assessing the progression of neoplastic disease.
Aim of the study/research hypothesis: the aim of the project is to clinically validate the value of the ctDNA test as a tool for early diagnosis of recurrence, assessment of cancer progression, the prognosis of treatment effects, and monitoring of therapy in patients with primary liver HCC or colorectal cancer metastases.
Read more
Description of the methodology: The main objective of the work will be achieved through the implementation of specific objectives: 1) Recruitment of 300 patients, including 100 patients with colorectal liver limited metastasis, 100 patients with hepatocellular carcinoma (HCC) and 100 patients in the control group who will be qualified for liver resection or transplantation, and in whom ctDNA level testing will not be tested. 2) Taking blood samples from the patients. The detection of ctDNA requires only the collection of 10 ml of the patient's blood and the collection of specimens from the tumor after resection. Blood will be collected before, one month, and 6 months after surgery during routine oncology check-ups. Tumor specimens will be taken from the backside table and sent for final histopathological examination. Control "follow-up" will take place for 18 months from the first ctDNA blood collection.
Based on the collected material, genetic analysis will be performed. In the first stage, a tumor section taken during liver resection, and DNA from the patient's blood will be analyzed the molecular (genetic) signature of the patient's tumor will be determined and several genetic changes characteristic of the change will be selected. Thereafter, the presence of the selected genetic variants will be assessed qualitatively and quantitatively in the pre-operative blood sample and all subsequent post-operative blood samples.
The investigators assume that in a blood sample taken 4 weeks after surgery, ctDNA should be undetectable or detected at a low level. In order to assess the change in the level of ctDNA in the postoperative period, a third examination will be performed - 6 months after the operation. Any level of detected ctDNA will be considered significant.
Each increase in the level of the analyzed mutations will indicate the potential progression of the disease. The results of molecular analyzes will be correlated with the assessment of imaging tests and the level of tumor markers performed as part of routine oncological control.
This is a prospective observational study with a defined study group. These are patients with colorectal cancer metastases limited to the liver, i.e. stage IV of the cancer process, or patients with hepatocellular carcinoma (HCC) qualified for radical surgery or liver transplantation. Patients in the control group (without ctDNA tests) will be treated in accordance with the best clinical knowledge and accepted international recommendations.
The statistical analysis of the results will use the SAS (Statistical Analysis System) software, considering the Kaplan-Meier method, log-rank tests, Cox proportional hazards regression, and logistic regression.
The investigators hypothesize that the use of ctDNA will enable the identification of early disease progression or will identify patients with the highest risk of recurrence. In addition, it will improve the supervision of diseases and enable possible modification of treatment in patients with stage IV colorectal cancer or patients after liver resection or transplantation for HCC. In the future, oncological prevention will consist in blood tests, which will enable early detection of even those cancers that show symptoms only at an advanced stage, which will potentially improve the effectiveness of treatment.
Read the detailed description
Health problem Hepatocellular carcinoma (HCC) is the most common primary malignant tumor of the liver. It is estimated that it accounts for 80-90% all cases of liver cancer. Liver cancer is one of the faster growing and worse prognosis cancers. It constitutes approximately 5.4% of all malignant tumors.
Colorectal cancer (CRC) is currently the third most common cancer in the world and in Poland. Every year in the Polish population about 20,000 people will be diagnosed with colorectal cancer. Most of them will be diagnosed in the advanced stage IV of the disease. About 50% of CRC patients will develop liver metastases during the natural course of disease progression. Surgery for liver metastases is the only potential treatment. Even after tumor resection surgery, the disease may continue to develop even if the patient is undergoing chemotherapy.
Furthermore, the accuracy and sensitivity of pathological and imaging methods for disease progression or molecular identification of residual disease (MRD) are limited, while when the specificity and clinical diagnostic utility of serum markers (CEA) is poor. CT/MRI/PET being part of the standard surveillance program increases ability to detect recurrences, but are not sensitive enough for small lesions, especially in patients after liver resection or modern chemotherapy, i.e. targeted therapy. Most patients have no measurable disease based on imaging until an obvious recurrence occurs. Often it is too late for any intervention. Each recurrence of the disease is also a failure of the chemotherapy. In addition, second line chemotherapy is less likely to work success in terms of long-term patient survival. Therefore, there is an urgent need to improve approaches to long-term non-invasive tumor monitoring and predict recurrence earlier than standard imaging, and to evaluate the effect of surgical intervention and chemotherapy, especially in stage IV cancer.
The awarding criterion - HCC is a rare disease. Awarding criterion - the area of surgery and diagnostics.
In the case of patients with colorectal cancer, the target group of patients to be included in the study are patients over 18 years of age with metastases of colorectal cancer. Colon limited to the liver, with no history of cancer other than colorectal cancer. The study will include synchronous and metachronous metastases according to: new definition.
In the case of hepatocellular carcinoma (HCC), the target group is patients with resectable HCC, in the case of liver resection or unresectable HCC in the case of liver transplantation. The study will include patients with or without cirrhosis. Qualification for liver transplantation and indication for transplantation liver disease will be taken into account, among others, using the French model of HCC (calculator), which takes into account the size and number of lesions and the AFP level.
Patients with or without cirrhosis will be qualified for liver resection. The group will include patients from the age of 18 to the age of 75 in the case resection and all patients qualified for liver transplantation at the liver transplantation qualification meeting.
Patients with completely removed primary tumor in the large intestine will be in the study group.
Chemotherapy is not an indication for the study. According to treatment standards, the vast majority of patients with colorectal cancer and/or metastases will undergo treatment chemotherapy. Currently, not enough scientific research has been conducted to determine how and whether chemotherapy administered to patients affects the results ctDNA. Additionally, the study assumes that patients will be covered by the standard of care in this group of patients.
Patients with extrahepatic lesions will not be included in the study. Patients with rapid disease progression on chemotherapy with a 6-month survival period uncertain will not be included in the research. Patients older than 75 years of age will also not be included in the study.
Patients undergoing steroid therapy and diagnosed with autoimmune diseases will not be included in the study.
The goal of surgical treatment is to achieve R0 resection of all liver metastases. Patients after liver resection with radiologically visible recurrence will undergo treatment further treatment according to the decision of the oncology team. Hepatic and extrahepatic recurrence does not exclude the patient from the study.
Detailed treatment protocol
- Qualification of the patient for liver resection or transplantation. Assessment of patients at an oncology consultation.
- Obtaining informed consent to participate in the study.
- Randomization of patients in a 2:1 ratio by drawing a code indicating ctDNA testing (control group - without ctDNA testing)
- Assessment of the patient immediately before surgery.
- Physical and subjective examination. i. Assessment of quality of life using the Polish version of the EORTC QLQ-C30 form b. Performing laboratory and imaging tests in accordance with local protocol. i. Biochemical tests ii. Imaging tests 4. Collecting 10ml of blood for gDNA and ctDNA testing along with routine preoperative blood collection.
- Surgery 6. Liver resection or orthotopic liver transplantation from a deceased donor. 8. Monitoring the patient in the surgical intensive care unit. 9. Monitoring the patient in the general room at the Department of General, Transplantation and Liver Surgery.
- Discharge of the patient home and completion of surgical treatment. 11. Monitoring the patient in the general room of the Hepatology Clinic in the case of transplantation or in the Polyclinic in the case of liver resection.
- Transplantation/surgical outpatient clinic: Assessment on the 30th day (with a deviation of 2-3 days) after surgery in terms of the occurrence of postoperative complications, assessment general examination of the patient and 2 taking a blood sample for ctDNA testing.
- Transplant/surgical outpatient clinic: Assessment in the 6th month (with a deviation of a few days) after surgery in terms of the patient's general condition and possible recurrence cancer process, taking a third blood sample for ctDNA testing. 14. Transplant/surgical outpatient clinic: Monitoring the cancer process and assessing patients one year after resection/transplantation.
- End of the observation period of patients 12 months after the last collection
- Being tested
- Tumor Tissue Collection and NGS, Blood Collection for Plasma ctDNA, ctDNA Mutation Analysis via ddPCR
- Keywords
- ctDNA, MRD, CRC, HCC
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tumor Tissue Collection and NGSDiagnostic test
Tumor tissue is collected during surgery and used for DNA extraction. Next-Generation Sequencing (NGS) is performed to identify oncogenic mutations.
Blood Collection for Plasma ctDNAOther
Blood is collected at three time points: one day before surgery, one month, and six months after surgery. Plasma is separated and used for further molecular analysis or storage.
ctDNA Mutation Analysis via ddPCRDiagnostic test
Circulating tumor DNA (ctDNA) is isolated from plasma samples. Mutations previously identified by NGS are quantitatively analyzed using droplet digital PCR (ddPCR).
| Study group | Role | What they receive |
|---|---|---|
| Study Group - Colorectal Cancer with Liver Metastases | Other | Patients with metastatic colorectal cancer to the liver. Tumor tissue obtained during surgery is subjected to DNA extraction and Next-Generation Sequencing (NGS) to identify oncogenic mutations. Blood samples are collected one day before surgery, one month, and six months after surgery. Plasma is separated from blood to isolate circulating tumor DNA (ctDNA), which is then tested using droplet digital PCR (ddPCR) to detect the mutations previously identified by NGS. Receives: Diagnostic Test: Tumor Tissue Collection and NGS; Other: Blood Collection for Plasma ctDNA; Diagnostic Test: ctDNA Mutation Analysis via ddPCR |
| Study Group - Hepatocellular Carcinoma | Other | Patients with hepatocellular carcinoma. Tumor tissue collected during surgery is analyzed using NGS to identify oncogenic mutations. Blood samples are collected at the same three time points. Plasma-derived ctDNA is tested using ddPCR for the previously detected mutations. Receives: Diagnostic Test: Tumor Tissue Collection and NGS; Other: Blood Collection for Plasma ctDNA; Diagnostic Test: ctDNA Mutation Analysis via ddPCR |
| Control Group - Colorectal Cancer with Liver Metastases | Other | Patients with metastatic colorectal cancer to the liver meeting control group criteria. Blood samples are collected one day before surgery, one month, and six months after surgery. Plasma is separated and stored, but no NGS or ddPCR analyses are performed. Receives: Other: Blood Collection for Plasma ctDNA |
| Control Group - Hepatocellular Carcinoma | Other | Patients with hepatocellular carcinoma meeting control group criteria. Blood is collected at three predefined time points. Plasma is separated and stored. No molecular or genetic testing is conducted on these samples. Receives: Other: Blood Collection for Plasma ctDNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the clinical value of ctDNA level
Assessment of the ctDNA concentration one day before surgery.
Measured: One day before surgery - first day of enrollment
Assessment of the clinical value of ctDNA level
Assessment of the ctDNA concentration one month after surgery
Measured: From enrollment to 30 days after a surgery.
Assessment of the clinical value of ctDNA level
Assessment of the ctDNA concentration 6 months after surgery.
Measured: From enrollment to 6 months after a surgery.
Assessment of the mutational status of patient cancer
Determining the mutation status of the patient's cancer tissue by performing next-generation sequencing
Measured: From enrollment to 6 months after a surgery.
Assessment of the mutational status of patient cancer
Determining the mutation status of the patient's cancer by performing ddPCR reaction.
Measured: From enrollment to 6 months after a surgery.
Assessment of the mutational status of patient cancer 30 days after surgery
Determination of mutation status in plasma, 30 days after the patient's surgery by performing ddPCR reaction. This study aims to determine the rate of tumor recurrence.
Measured: From enrollment to 6 months after a surgery.
Assessment of the mutational status of patient cancer 6 months after surgery
Determination of mutation status in plasma, 6 months after the patient's surgery by performing ddPCR reaction. This study aims to determine the rate of tumor recurrence.
Measured: From enrollment to 6 months after a surgery.
Secondary outcomes (2)
Assessment of quality of life
Assessment of quality of life using the Polish version of the EORTC QLQ-C30 form. The statistical analysis of the results will use the SAS (Statistical Analysis System) software, considering the Kaplan-Meier method, log-rank tests, Cox proportional hazards regression, and logistic regression.
Measured: From enrollment to 4 years after a surgery.
Comparative evaluation of imaging results with molecular results
Evaluation of alpha-fetoprotein (AFP), carcinoembryonic antigen (CEA), and Ca19-9 antigen levels and their comparison with ctDNA results
Measured: From enrollment to 4 years after a surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2025
- Study start1 Jan 2025
- Primary completion1 Feb 2027 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HCC - Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Agency, Poland
- Responsible party
- Principal investigator, Oskar Kornasiewicz, Medical University of Warsaw
- Investigators
- Tomasz Stokłosa, Professor, Principal investigator, tomasz.stoklosa@wum.edu.pl
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07001085
- Sponsor's protocol ID
- 1WB1
- Other IDs
- 2023/ABM/01/00068
- Status last verified
- Jan 2025
- First submitted
- 9 May 2025
- Last updated
- 3 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Gorzynska I, Kornasiewicz O, Koniczka A, Moskowicz A, Skubisz K, Peplowski J, Lesiak A, Stoklosa T, Wojcicka A, Grat M. Circulating tumor DNA-based assessment of disease progression after liver resection or transplantation for metastatic colorectal cancer or hepatocellular carcinoma-study protocol for a randomized, controlled trial. Trials. 2026 May 26;27(1):506. doi: 10.1186/s13063-026-09790-5.
PubMed 42185926
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Trial Assessing the Impact of ctDNA Testing in Patients After Liver Resection or Transplantation Due to Metastases From Colorectal Cancer or Hepatocellular Carcinoma (HCC) on Treatment Strategies and Long-term Survival"
- ClinicalTrials.gov ID
- NCT07001085
- Acronym / sponsor ID
- 1WB1
- Keywords
- ctDNA, MRD, CRC, HCC
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Collaborators
- Medical Research Agency, Poland
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 3 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
"Liquid biopsy" is a collective term that refers to the analysis of cancer-derived biomarkers isolated from the biological fluids of cancer patients. The analysis of these blood components can be used for early cancer detection, staging, prognosis, drug resistance monitoring, and minimal residual disease (MRD) monitoring. The "liquid biopsy" is based on the fact that cancer cells release their DNA into the bloodstream, known as ctDNA (circulating tumor DNA). A sample of the patient's peripheral blood is sufficient to test ctDNA. There have been many studies in the literature on the usefulness of liquid biopsy in the treatment of various malignancies, such as breast cancer, prostate cancer, and colorectal cancer. However, this has been a lack of prospectively obtained data analyzing the impact on the ctDNA assessment of the progression and recurrence of the primary disease or the type of treatment applied to improve long-term survival. The ctDNA test is not a widely recognized technology for assessing the progression of neoplastic disease.
Aim of the study/research hypothesis: the aim of the project is to clinically validate the value of the ctDNA test as a tool for early diagnosis of recurrence, assessment of cancer progression, the prognosis of treatment effects, and monitoring of therapy in patients with primary liver HCC or colorectal cancer metastases.
Description of the methodology: The main objective of the work will be achieved through the implementation of specific objectives: 1) Recruitment of 300 patients, including 100 patients with colorectal liver limited metastasis, 100 patients with hepatocellular carcinoma (HCC) and 100 patients in the control group who will be qualified for liver resection or transplantation, and in whom ctDNA level testing will not be tested. 2) Taking blood samples from the patients. The detection of ctDNA requires only the collection of 10 ml of the patient's blood and the collection of specimens from the tumor after resection. Blood will be collected before, one month, and 6 months after surgery during routine oncology check-ups. Tumor specimens will be taken from the backside table and sent for final histopathological examination. Control "follow-up" will take place for 18 months from the first ctDNA blood collection.
Based on the collected material, genetic analysis will be performed. In the first stage, a tumor section taken during liver resection, and DNA from the patient's blood will be analyzed the molecular (genetic) signature of the patient's tumor will be determined and several genetic changes characteristic of the change will be selected. Thereafter, the presence of the selected genetic variants will be assessed qualitatively and quantitatively in the pre-operative blood sample and all subsequent post-operative blood samples.
The investigators assume that in a blood sample taken 4 weeks after surgery, ctDNA should be undetectable or detected at a low level. In order to assess the change in the level of ctDNA in the postoperative period, a third examination will be performed - 6 months after the operation. Any level of detected ctDNA will be considered significant.
Each increase in the level of the analyzed mutations will indicate the potential progression of the disease. The results of molecular analyzes will be correlated with the assessment of imaging tests and the level of tumor markers performed as part of routine oncological control.
This is a prospective observational study with a defined study group. These are patients with colorectal cancer metastases limited to the liver, i.e. stage IV of the cancer process, or patients with hepatocellular carcinoma (HCC) qualified for radical surgery or liver transplantation. Patients in the control group (without ctDNA tests) will be treated in accordance with the best clinical knowledge and accepted international recommendations.
The statistical analysis of the results will use the SAS (Statistical Analysis System) software, considering the Kaplan-Meier method, log-rank tests, Cox proportional hazards regression, and logistic regression.
The investigators hypothesize that the use of ctDNA will enable the identification of early disease progression or will identify patients with the highest risk of recurrence. In addition, it will improve the supervision of diseases and enable possible modification of treatment in patients with stage IV colorectal cancer or patients after liver resection or transplantation for HCC. In the future, oncological prevention will consist in blood tests, which will enable early detection of even those cancers that show symptoms only at an advanced stage, which will potentially improve the effectiveness of treatment.
Detailed description
Health problem Hepatocellular carcinoma (HCC) is the most common primary malignant tumor of the liver. It is estimated that it accounts for 80-90% all cases of liver cancer. Liver cancer is one of the faster growing and worse prognosis cancers. It constitutes approximately 5.4% of all malignant tumors.
Colorectal cancer (CRC) is currently the third most common cancer in the world and in Poland. Every year in the Polish population about 20,000 people will be diagnosed with colorectal cancer. Most of them will be diagnosed in the advanced stage IV of the disease. About 50% of CRC patients will develop liver metastases during the natural course of disease progression. Surgery for liver metastases is the only potential treatment. Even after tumor resection surgery, the disease may continue to develop even if the patient is undergoing chemotherapy.
Furthermore, the accuracy and sensitivity of pathological and imaging methods for disease progression or molecular identification of residual disease (MRD) are limited, while when the specificity and clinical diagnostic utility of serum markers (CEA) is poor. CT/MRI/PET being part of the standard surveillance program increases ability to detect recurrences, but are not sensitive enough for small lesions, especially in patients after liver resection or modern chemotherapy, i.e. targeted therapy. Most patients have no measurable disease based on imaging until an obvious recurrence occurs. Often it is too late for any intervention. Each recurrence of the disease is also a failure of the chemotherapy. In addition, second line chemotherapy is less likely to work success in terms of long-term patient survival. Therefore, there is an urgent need to improve approaches to long-term non-invasive tumor monitoring and predict recurrence earlier than standard imaging, and to evaluate the effect of surgical intervention and chemotherapy, especially in stage IV cancer.
The awarding criterion - HCC is a rare disease. Awarding criterion - the area of surgery and diagnostics.
In the case of patients with colorectal cancer, the target group of patients to be included in the study are patients over 18 years of age with metastases of colorectal cancer. Colon limited to the liver, with no history of cancer other than colorectal cancer. The study will include synchronous and metachronous metastases according to: new definition.
In the case of hepatocellular carcinoma (HCC), the target group is patients with resectable HCC, in the case of liver resection or unresectable HCC in the case of liver transplantation. The study will include patients with or without cirrhosis. Qualification for liver transplantation and indication for transplantation liver disease will be taken into account, among others, using the French model of HCC (calculator), which takes into account the size and number of lesions and the AFP level.
Patients with or without cirrhosis will be qualified for liver resection. The group will include patients from the age of 18 to the age of 75 in the case resection and all patients qualified for liver transplantation at the liver transplantation qualification meeting.
Patients with completely removed primary tumor in the large intestine will be in the study group.
Chemotherapy is not an indication for the study. According to treatment standards, the vast majority of patients with colorectal cancer and/or metastases will undergo treatment chemotherapy. Currently, not enough scientific research has been conducted to determine how and whether chemotherapy administered to patients affects the results ctDNA. Additionally, the study assumes that patients will be covered by the standard of care in this group of patients.
Patients with extrahepatic lesions will not be included in the study. Patients with rapid disease progression on chemotherapy with a 6-month survival period uncertain will not be included in the research. Patients older than 75 years of age will also not be included in the study.
Patients undergoing steroid therapy and diagnosed with autoimmune diseases will not be included in the study.
The goal of surgical treatment is to achieve R0 resection of all liver metastases. Patients after liver resection with radiologically visible recurrence will undergo treatment further treatment according to the decision of the oncology team. Hepatic and extrahepatic recurrence does not exclude the patient from the study.
Detailed treatment protocol
- Qualification of the patient for liver resection or transplantation. Assessment of patients at an oncology consultation.
- Obtaining informed consent to participate in the study.
- Randomization of patients in a 2:1 ratio by drawing a code indicating ctDNA testing (control group - without ctDNA testing)
- Assessment of the patient immediately before surgery.
- Physical and subjective examination. i. Assessment of quality of life using the Polish version of the EORTC QLQ-C30 form b. Performing laboratory and imaging tests in accordance with local protocol. i. Biochemical tests ii. Imaging tests 4. Collecting 10ml of blood for gDNA and ctDNA testing along with routine preoperative blood collection.
- Surgery 6. Liver resection or orthotopic liver transplantation from a deceased donor. 8. Monitoring the patient in the surgical intensive care unit. 9. Monitoring the patient in the general room at the Department of General, Transplantation and Liver Surgery.
- Discharge of the patient home and completion of surgical treatment. 11. Monitoring the patient in the general room of the Hepatology Clinic in the case of transplantation or in the Polyclinic in the case of liver resection.
- Transplantation/surgical outpatient clinic: Assessment on the 30th day (with a deviation of 2-3 days) after surgery in terms of the occurrence of postoperative complications, assessment general examination of the patient and 2 taking a blood sample for ctDNA testing.
- Transplant/surgical outpatient clinic: Assessment in the 6th month (with a deviation of a few days) after surgery in terms of the patient's general condition and possible recurrence cancer process, taking a third blood sample for ctDNA testing. 14. Transplant/surgical outpatient clinic: Monitoring the cancer process and assessing patients one year after resection/transplantation.
- End of the observation period of patients 12 months after the last collection
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Study Group - Colorectal Cancer with Liver Metastases | Other | Diagnostic Test: Tumor Tissue Collection and NGS, Other: Blood Collection for Plasma ctDNA, Diagnostic Test: ctDNA Mutation Analysis via ddPCRPatients with metastatic colorectal cancer to the liver. Tumor tissue obtained during surgery is subjected to DNA extraction and Next-Generation Sequencing (NGS) to identify oncogenic mutations. Blood samples are collected one day before surgery, one month, and six months after surgery. Plasma is separated from blood to isolate circulating tumor DNA (ctDNA), which is then tested using droplet digital PCR (ddPCR) to detect the mutations previously identified by NGS. |
| Study Group - Hepatocellular Carcinoma | Other | Diagnostic Test: Tumor Tissue Collection and NGS, Other: Blood Collection for Plasma ctDNA, Diagnostic Test: ctDNA Mutation Analysis via ddPCRPatients with hepatocellular carcinoma. Tumor tissue collected during surgery is analyzed using NGS to identify oncogenic mutations. Blood samples are collected at the same three time points. Plasma-derived ctDNA is tested using ddPCR for the previously detected mutations. |
| Control Group - Colorectal Cancer with Liver Metastases | Other | Other: Blood Collection for Plasma ctDNAPatients with metastatic colorectal cancer to the liver meeting control group criteria. Blood samples are collected one day before surgery, one month, and six months after surgery. Plasma is separated and stored, but no NGS or ddPCR analyses are performed. |
| Control Group - Hepatocellular Carcinoma | Other | Other: Blood Collection for Plasma ctDNAPatients with hepatocellular carcinoma meeting control group criteria. Blood is collected at three predefined time points. Plasma is separated and stored. No molecular or genetic testing is conducted on these samples. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- age 18-75 years of both sexes;
- patients with synchronous or metachronous metastases of colorectal cancer limited to the liver after complete removal of the primary lesion from the intestine qualified for liver resection or transplantation;
- or patients with resectable or unresectable HCC scheduled for liver resection or transplantation
- no history of other cancers;
- negative virological status in the case of mCRC;
Key exclusion criteria (10 listed)
- age under 18 and over 75;
- pregnancy
- patients with extrahepatic metastases visible in imaging studies;
- metabolic and autoimmune diseases or chronic immunosuppressive treatment other than in the group of patients after liver transplantation due to HCC;
- positive virological status, excluding the group of patients with HCC;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tumor Tissue Collection and NGSTumor tissue is collected during surgery and used for DNA extraction. Next-Generation Sequencing (NGS) is performed to identify oncogenic mutations. | Diagnostic test | Study Group - Colorectal Cancer with Liver Metastases, Study Group - Hepatocellular Carcinoma |
| Blood Collection for Plasma ctDNABlood is collected at three time points: one day before surgery, one month, and six months after surgery. Plasma is separated and used for further molecular analysis or storage. | Other | Control Group - Colorectal Cancer with Liver Metastases, Control Group - Hepatocellular Carcinoma, Study Group - Colorectal Cancer with Liver Metastases, Study Group - Hepatocellular Carcinoma |
| ctDNA Mutation Analysis via ddPCRCirculating tumor DNA (ctDNA) is isolated from plasma samples. Mutations previously identified by NGS are quantitatively analyzed using droplet digital PCR (ddPCR). | Diagnostic test | Study Group - Colorectal Cancer with Liver Metastases, Study Group - Hepatocellular Carcinoma |
Primary outcome
Assessment of the clinical value of ctDNA level
Time frame: One day before surgery - first day of enrollment
Assessment of the ctDNA concentration one day before surgery.
Assessment of the clinical value of ctDNA level
Time frame: From enrollment to 30 days after a surgery.
Assessment of the ctDNA concentration one month after surgery
Assessment of the clinical value of ctDNA level
Time frame: From enrollment to 6 months after a surgery.
Assessment of the ctDNA concentration 6 months after surgery.
Assessment of the mutational status of patient cancer
Time frame: From enrollment to 6 months after a surgery.
Determining the mutation status of the patient's cancer tissue by performing next-generation sequencing
Assessment of the mutational status of patient cancer
Time frame: From enrollment to 6 months after a surgery.
Determining the mutation status of the patient's cancer by performing ddPCR reaction.
Assessment of the mutational status of patient cancer 30 days after surgery
Time frame: From enrollment to 6 months after a surgery.
Determination of mutation status in plasma, 30 days after the patient's surgery by performing ddPCR reaction. This study aims to determine the rate of tumor recurrence.
Assessment of the mutational status of patient cancer 6 months after surgery
Time frame: From enrollment to 6 months after a surgery.
Determination of mutation status in plasma, 6 months after the patient's surgery by performing ddPCR reaction. This study aims to determine the rate of tumor recurrence.
2 secondary outcomes
Assessment of quality of life
Time frame: From enrollment to 4 years after a surgery.
Comparative evaluation of imaging results with molecular results
Time frame: From enrollment to 4 years after a surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
- Derived from this study: PubMed 42185926Gorzynska I, Kornasiewicz O, Koniczka A, Moskowicz A, Skubisz K, Peplowski J, Lesiak A, Stoklosa T, Wojcicka A, Grat M. Circulating tumor DNA-based assessment of disease progression after liver resection or transplantation for metastatic colorectal cancer or hepatocellular carcinoma-study protocol for a randomized, controlled trial. Trials. 2026 May 26;27(1):506. doi: 10.1186/s13063-026-09790-5.
- Individual participant dataSharing planned: Yes
Related trials for HCC - Hepatocellular Carcinoma
RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingObservational study
A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice
Lung Cancer, Hepatocellular Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tomasz Stokłosa, Professor principal investigator
tomasz.stoklosa@wum.edu.pl
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tumor Tissue Collection and NGS, Blood Collection for Plasma ctDNA and ctDNA Mutation Analysis via ddPCR in people with HCC - Hepatocellular Carcinoma and Colorectal Cancer Metastatic, run by Medical University of Warsaw at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Izabela Górzyńska, Associate Professor (22 599 25 45, oskar.kornasiewicz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the clinical value of ctDNA level (time frame: One day before surgery - first day of enrollment). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07001085, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2025.