Recurrent Liver CancerNCT06430983
Recurrent Liver Cancer: Reconceptualization and Reevaluation
An observational study of Recurrent Liver Cancer and Primary Liver Cancer, run by Nanjing Medical University at 1 site in China.
Trial summary
The goal of this observational study is to determine if a specific protein can serve as a novel indicator for the recurrence of liver cancer. The study will focus on recurrent liver cancer patients and compare participants to primary liver cancer patients as controls. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Recurrent Liver Cancer, Primary Liver Cancer
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2024to 1 Oct 2027
- How long will I take part?
- 2 Years
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population includes patients with primary hepatocellular carcinoma (HCC) and non-HCC liver cancers. Inclusion criteria are: diagnosis of primary HCC or non-HCC, ability to provide informed consent, agreement to supply blood samples, and clinical data completeness. Exclusion criteria include pregnancy, organ transplantation, other tumor diagnoses in non-HCC patients, HCC with other tumors, and researcher-determined ineligibility. The sample size is limited to ensure data precision and study validity.
Who may be able to join
- Diagnosed with primary hepatocellular carcinoma or diagnosed with non-HCC
- The patient or the patient's legal representative must be able to read, understand, and sign the informed consent form
- Agree to provide blood samples and have good clinical compliance
- Complete clinical basic information, including: the patient's unique traceability number (ID card number/outpatient number/health insurance card number), age, gender, imaging and/or pathological diagnosis results (for patients with primary liver disease), imaging examination confirmed heteromorphic liver cancer (for non-HCC patients)
Who cannot join
- Pregnant women
- Those who have received organ transplantation
- Non-HCC patients diagnosed with other tumors
- Patients with primary hepatocellular carcinoma complicated by other tumors
- Those judged by the researcher as not meeting the inclusion criteria
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210000
yewei zhang, +86 13813885788, zhangyewei@njmu.edu.cn
About this study
The goal of this observational study is to determine if a specific protein can serve as a novel indicator for the recurrence of liver cancer. The study will focus on recurrent liver cancer patients and compare participants to primary liver cancer patients as controls. The primary purpose is to assess whether the elevated levels of this protein can be used to monitor the recurrence of liver cancer.
The main questions it aims to answer are:
Read more
Is the levels of the protein significantly elevated in recurrent liver cancer patients compared to primary liver cancer patients? Can the protein be used as a reliable biomarker for the early detection of liver cancer recurrence?
Researchers will compare the protein levels in the following groups:
50 recurrent liver cancer patients (training set) with abnormally high levels of the protein.
250 recurrent liver cancer patients (validation set) to confirm the protein's elevation in a separate cohort.
Participants will be required to:
- Provide blood samples for protein analysis.
- Undergo regular follow-up visits for monitoring and data collection.
- Allow access to their medical records for relevant clinical information.
Read the detailed description
As part of the patient registry, investigators will implement the following registration procedures and other quality factors:
Screening and Recruitment: Eligible patients will be screened and recruited through hospital liver cancer outpatient clinics and wards. Patients must meet the diagnostic criteria for recurrent or primary liver cancer and be willing to participate in the study.
Data Collection: Clinical information of participants will be collected, including demographic characteristics, medical history, treatment regimens, and follow-up outcomes. Data will be entered and verified by professionals to ensure accuracy and completeness.
Quality Control: Strict quality control measures will be implemented, including data audits, sample management, and laboratory testing. Regular reviews and validations of the data will be conducted to ensure the reliability and replicability of the study results.
Data Security: The privacy and personal information of participants will be protected. All data will be stored in a secure environment and comply with relevant laws, regulations, and ethical guidelines.
Ethical Review: The research protocol has been approved by the ethics committee, ensuring that the conduct of the study meets ethical standards and the protection of patient rights.
- Conditions
- Recurrent Liver Cancer, Primary Liver Cancer
- Keywords
- Recurrent Liver Cancer, Primary Liver Cancer
- Medical subject headings
- Liver Neoplasms, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Training Set for Recurrent Liver Cancer Patient | The training set for recurrent liver cancer patients is a subset of data collected from individuals who have been diagnosed with liver cancer that has returned after a period of remission or initial treatment. This data set is used to train machine learning models or other statistical methods to identify patterns or biomarkers that are indicative of cancer recurrence. The training set typically includes information such as patient demographics, medical history, previous treatments, and biological data, such as genetic mutations, protein levels, or imaging results. The goal is to use this data to develop a model that can accurately predict the recurrence of liver cancer in other patients, which can then be validated and tested using a separate data set, known as the validation set. | |
| Validation Set for Recurrent Liver Cancer Patient | The validation set for recurrent liver cancer patients is a distinct subset of data that is used to assess the performance and generalizability of a model or hypothesis developed from a training set. This set includes data from patients with recurrent liver cancer who were not part of the original training set. The purpose of the validation set is to test the model's ability to accurately predict or classify cases of recurrent liver cancer in a population that it has not been exposed to during its training phase. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and Specificity of the Novel Protein Indicator
The primary outcome is to determine the sensitivity and specificity of the novel protein indicator in predicting the recurrence of liver cancer. This will be assessed by constructing a Receiver Operating Characteristic (ROC) curve and establishing a threshold value that maximizes the true positive rate (sensitivity) and minimizes the false positive rate (1-specificity). The ROC curve will visually represent the trade-off between sensitivity and specificity for different threshold values.
Measured: Assessed at the end of the study (up to 3 years), once all patient data has been collected and analyzed.
Positive and Negative Predictive Values
The secondary outcome is to calculate the positive predictive value (PPV) and negative predictive value (NPV) of the novel protein indicator. The PPV represents the probability that patients with an elevated indicator level will experience cancer recurrence, while the NPV represents the probability that patients with a non-elevated indicator level will remain free of recurrence. These values will provide insight into the clinical utility of the indicator.
Measured: Calculated after the threshold value has been determined and applied to the patient data (up to 3 years).
Secondary outcomes (4)
Overall Survival (OS)
Overall survival (OS) is a critical endpoint that measures the length of time from the start of the study until the death of a patient. It provides an assessment of the long-term outcome for patients with liver cancer and will be used to evaluate the prognostic value of the novel protein indicator.
Measured: Monitored throughout the study and reported at 1 year, 2 years, and study completion (up to 5 years).
Progression-Free Survival (PFS)
Progression-free survival (PFS) is the length of time during and after the treatment of a disease that a patient lives without the disease getting worse. In the context of this study, PFS will be used to measure the time from study entry until the cancer progresses or the patient dies from any cause, providing an intermediate endpoint that reflects the control of disease progression.
Measured: Assessed at each follow-up visit, every 3 months for the first 2 years, then every 6 months until study completion (up to 5 years).
Disease-Free Survival (DFS)
Disease-free survival (DFS) is the period after treatment during which there is no evidence of active cancer. It is a measure of the effectiveness of treatment in eliminating cancer cells. DFS will be calculated from the time of treatment initiation until the first sign of cancer recurrence or the end of the study.
Measured: Monitored and reported at 6 months, 1 year, 2 years, and study completion (up to 5 years).
Time to Progression (TTP)
Time to progression (TTP) is the interval from the start of treatment until the tumor progresses or the patient's condition worsens to a defined level. This endpoint is particularly relevant for evaluating the effectiveness of the novel protein indicator in predicting and monitoring disease progression.
Measured: Measured from the initiation of the study intervention until progression or defined worsening, assessed at each follow-up visit (every 3 months for the first 2 years, then every 6 months until study completion, up to 5 years).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2024
- Study start1 Jul 2024
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Liver CancerStudies of the same condition, open and under way.
- More trials run by Nanjing Medical UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yewei Zhang, Nanjing Medical University
- Investigators
- zhang yewei, doctor, Study chair, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06430983
- Sponsor's protocol ID
- 2024KY16401
- Status last verified
- Dec 2024
- First submitted
- 16 May 2024
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recurrent Liver Cancer: Reconceptualization and Reevaluation
- ClinicalTrials.gov ID
- NCT06430983
- Acronym / sponsor ID
- 2024KY16401
- Conditions
- Recurrent Liver Cancer, Primary Liver Cancer
- Keywords
- Recurrent Liver Cancer, Primary Liver Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 28 May 2024 (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.
The goal of this observational study is to determine if a specific protein can serve as a novel indicator for the recurrence of liver cancer. The study will focus on recurrent liver cancer patients and compare participants to primary liver cancer patients as controls. The primary purpose is to assess whether the elevated levels of this protein can be used to monitor the recurrence of liver cancer.
The main questions it aims to answer are:
Is the levels of the protein significantly elevated in recurrent liver cancer patients compared to primary liver cancer patients? Can the protein be used as a reliable biomarker for the early detection of liver cancer recurrence?
Researchers will compare the protein levels in the following groups:
50 recurrent liver cancer patients (training set) with abnormally high levels of the protein.
250 recurrent liver cancer patients (validation set) to confirm the protein's elevation in a separate cohort.
Participants will be required to:
- Provide blood samples for protein analysis.
- Undergo regular follow-up visits for monitoring and data collection.
- Allow access to their medical records for relevant clinical information.
Detailed description
As part of the patient registry, investigators will implement the following registration procedures and other quality factors:
Screening and Recruitment: Eligible patients will be screened and recruited through hospital liver cancer outpatient clinics and wards. Patients must meet the diagnostic criteria for recurrent or primary liver cancer and be willing to participate in the study.
Data Collection: Clinical information of participants will be collected, including demographic characteristics, medical history, treatment regimens, and follow-up outcomes. Data will be entered and verified by professionals to ensure accuracy and completeness.
Quality Control: Strict quality control measures will be implemented, including data audits, sample management, and laboratory testing. Regular reviews and validations of the data will be conducted to ensure the reliability and replicability of the study results.
Data Security: The privacy and personal information of participants will be protected. All data will be stored in a secure environment and comply with relevant laws, regulations, and ethical guidelines.
Ethical Review: The research protocol has been approved by the ethics committee, ensuring that the conduct of the study meets ethical standards and the protection of patient rights.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training Set for Recurrent Liver Cancer Patient | – | –The training set for recurrent liver cancer patients is a subset of data collected from individuals who have been diagnosed with liver cancer that has returned after a period of remission or initial treatment. This data set is used to train machine learning models or other statistical methods to identify patterns or biomarkers that are indicative of cancer recurrence. The training set typically includes information such as patient demographics, medical history, previous treatments, and biological data, such as genetic mutations, protein levels, or imaging results. The goal is to use this data to develop a model that can accurately predict the recurrence of liver cancer in other patients, which can then be validated and tested using a separate data set, known as the validation set. |
| Validation Set for Recurrent Liver Cancer Patient | – | –The validation set for recurrent liver cancer patients is a distinct subset of data that is used to assess the performance and generalizability of a model or hypothesis developed from a training set. This set includes data from patients with recurrent liver cancer who were not part of the original training set. The purpose of the validation set is to test the model's ability to accurately predict or classify cases of recurrent liver cancer in a population that it has not been exposed to during its training phase. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes patients with primary hepatocellular carcinoma (HCC) and non-HCC liver cancers. Inclusion criteria are: diagnosis of primary HCC or non-HCC, ability to provide informed consent, agreement to supply blood samples, and clinical data completeness. Exclusion criteria include pregnancy, organ transplantation, other tumor diagnoses in non-HCC patients, HCC with other tumors, and researcher-determined ineligibility. The sample size is limited to ensure data precision and study validity.
Key inclusion criteria (4 listed)
- Diagnosed with primary hepatocellular carcinoma or diagnosed with non-HCC
- The patient or the patient's legal representative must be able to read, understand, and sign the informed consent form
- Agree to provide blood samples and have good clinical compliance
- Complete clinical basic information, including: the patient's unique traceability number (ID card number/outpatient number/health insurance card number), age, gender, imaging and/or pathological diagnosis results (for patients with primary liver disease), imaging examination confirmed heteromorphic liver cancer (for non-HCC patients)
Key exclusion criteria (5 listed)
- Pregnant women
- Those who have received organ transplantation
- Non-HCC patients diagnosed with other tumors
- Patients with primary hepatocellular carcinoma complicated by other tumors
- Those judged by the researcher as not meeting the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensitivity and Specificity of the Novel Protein Indicator
Time frame: Assessed at the end of the study (up to 3 years), once all patient data has been collected and analyzed.
The primary outcome is to determine the sensitivity and specificity of the novel protein indicator in predicting the recurrence of liver cancer. This will be assessed by constructing a Receiver Operating Characteristic (ROC) curve and establishing a threshold value that maximizes the true positive rate (sensitivity) and minimizes the false positive rate (1-specificity). The ROC curve will visually represent the trade-off between sensitivity and specificity for different threshold values.
Positive and Negative Predictive Values
Time frame: Calculated after the threshold value has been determined and applied to the patient data (up to 3 years).
The secondary outcome is to calculate the positive predictive value (PPV) and negative predictive value (NPV) of the novel protein indicator. The PPV represents the probability that patients with an elevated indicator level will experience cancer recurrence, while the NPV represents the probability that patients with a non-elevated indicator level will remain free of recurrence. These values will provide insight into the clinical utility of the indicator.
4 secondary outcomes
Overall Survival (OS)
Time frame: Monitored throughout the study and reported at 1 year, 2 years, and study completion (up to 5 years).
Progression-Free Survival (PFS)
Time frame: Assessed at each follow-up visit, every 3 months for the first 2 years, then every 6 months until study completion (up to 5 years).
Disease-Free Survival (DFS)
Time frame: Monitored and reported at 6 months, 1 year, 2 years, and study completion (up to 5 years).
Time to Progression (TTP)
Time frame: Measured from the initiation of the study intervention until progression or defined worsening, assessed at each follow-up visit (every 3 months for the first 2 years, then every 6 months until study completion, up to 5 years).
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 12 Dec 2024.
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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.
zhang yewei, doctor study chair
Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Recurrent Liver Cancer and Primary Liver Cancer, run by Nanjing Medical University at 1 site in China.
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 4 inclusion and 5 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 12 Dec 2024. 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 China. 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 zhang yewei, doctor (+86 13813885788, zhangyewei@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and Specificity of the Novel Protein Indicator (time frame: Assessed at the end of the study (up to 3 years), once all patient data has been collected and analyzed.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Dec 2024.