Colorectal CancerNCT06991452
Early Diagnosis and Recurrence Monitoring of Colorectal Cancer
An observational study of Colorectal Cancer, run by Huashan Hospital at 1 site in China.
Trial summary
Colorectal cancer (CRC) has an insidious onset and its survival rate is closely related to clinical stage. While the 5-year survival rate of stage I patients exceeds 90%, it drops to 14% in stage IV. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Liquid biopsy
- How many people
- 1,200 participants
- Where
- 1 siteChina
- Study dates
- May 2025to Nov 2027
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study will recruit a multi-center cohort of colorectal cancer patients (all stages), individuals with precancerous lesions (e.g., adenomas), and healthy controls. Participants must be ≥18 years old and capable of providing informed consent. This diverse population will enable training and external validation of a non-invasive AI-based diagnostic and prognostic model.
Who may be able to join
- 1: Inclusion criteria for the case group:
- Aged between 18 and 80 years old, regardless of gender.
- Patients diagnosed with early colorectal cancer in our hospital, with the following specific criteria:
- Meet the diagnostic criteria of the Chinese Colorectal Cancer Diagnosis and Treatment Guidelines (2023 Edition) of the National Health Commission of the People's Republic of China, and be diagnosed with primary colorectal cancer by pathological tissue examination based on the imaging features of endoscopy, CT/CT enhanced scanning or MRI;
- Accept the American Joint Committee on Cancer (AJCC)/Union for International Cancer Control (UICC) Colorectal Cancer TNM Staging System (8th Edition, 2017) evaluation, and be evaluated as stage I or II colorectal cancer (T1-4N0M0).
- Have not received radiotherapy, chemotherapy, immunotherapy, surgery and other treatments.
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- No history of other malignant tumors.
- Sign the informed consent form.
- 2: Inclusion criteria for participants in the control study with no obvious abnormalities in colonoscopy:
- Aged between 18 and 80 years old, regardless of gender.
- No abnormalities in colonoscopy results within the past 3 months.
- No history of malignant tumors, no family history of malignant tumors (first-degree relatives, i.e. parents and/or second-degree relatives, i.e. grandfather, grandmother, uncle, etc., do not have malignant tumors).
- No diseases such as obesity, hypertension, hyperlipidemia, metabolic syndrome, no bad living habits such as excessive drinking.
- Voluntarily sign the informed consent form and can strictly follow the trial protocol to complete the study.
- 3: Inclusion criteria for patients with non-neoplastic intestinal diseases:
- Aged between 18 and 80 years old, regardless of gender.
- Patients diagnosed with non-neoplastic intestinal diseases such as colorectal adenoma and inflammatory bowel disease by colonoscopy and pathological examination. No history of colorectal cancer.
- 4: Inclusion criteria for patients with non-intestinal malignancies:
- Aged between 18 and 80 years old, regardless of gender.
- Meet the latest diagnostic criteria of the National Health Commission of the People's Republic of China or the Chinese Medical Association, and be diagnosed with non-intestinal malignancies such as gastric cancer, liver cancer, pancreatic cancer, esophageal cancer, etc. by pathological examination in our hospital based on imaging features of endoscopy, CT/CT enhanced scanning or MRI, combined with clinical manifestations and relevant laboratory tests. Have not received radiotherapy, chemotherapy, immunotherapy, surgery, etc. No history of colorectal cancer.
- 5: Inclusion criteria for the chemotherapy resistance prediction team:
- Age between 18 and 80 years old, with no gender restrictions.
- Patients diagnosed with colorectal cancer in our hospital, with specific criteria as follows:
- Meeting the diagnostic criteria of the "Diagnosis and Treatment Guidelines for Colorectal Cancer in China (2023 Edition)" issued by the National Health Commission of the People's Republic of China, and confirmed as primary colorectal cancer through pathological tissue examination based on endoscopic, CT/CT enhanced scan or MRI imaging features;
- Evaluated by the American Joint Committee on Cancer (AJCC)/Union for International Cancer Control (UICC) colorectal cancer TNM staging system (8th Edition, 2017), and assessed as stage II or III colorectal cancer (T1-4N1-2M0). c) Have not received radiotherapy, chemotherapy, immunotherapy, surgery or other treatments.
- Evaluated as meeting surgical indications and planned to undergo radical surgery in three hospitals.
- No history of other malignant tumors in the past.
- Signed the informed consent form.
- 6: Inclusion Criteria for the Prediction Model of Colorectal Cancer Liver Metastasis:
- Age between 18 and 80 years old, with no gender restrictions.
- Patients diagnosed with colorectal cancer with liver metastasis in our hospital, with specific criteria as follows:
- Meeting the diagnostic criteria of the "Diagnosis and Treatment Guidelines for Colorectal Cancer in China (2023 Edition)" issued by the National Health Commission of the People's Republic of China, confirmed as primary colorectal cancer through endoscopy, liver ultrasound, CT/CT enhanced scan or MRI imaging features, and diagnosed with liver metastasis at the time of diagnosis;
- No previous treatment with radiotherapy, chemotherapy, immunotherapy, or surgery.
- No history of other malignant tumors.
- Signed informed consent form.
- 7: Inclusion criteria for the control group of the colorectal cancer liver metastasis cohort:
- Age between 18 and 80 years old, with no gender restrictions.
- Patients diagnosed with locally advanced colorectal cancer without distant metastasis in our hospital, with the following specific criteria:
- Meeting the diagnostic criteria of the "Diagnosis and Treatment Guidelines for Colorectal Cancer in China (2023 Edition)" issued by the National Health Commission of the People's Republic of China, and confirmed as primary colorectal cancer through pathological tissue examination based on endoscopic, CT/CT enhanced scan or MRI imaging features;
- Evaluated by the American Joint Committee on Cancer (AJCC)/Union for International Cancer Control (UICC) colorectal cancer TNM staging system (8th edition, 2017), the tumor invades the muscularis propria (T3), the perirectal fat (T4a), or adjacent organs (T4b), and/or has multiple local lymph node metastases (N1-2);
- Undergoing more than two imaging examinations (including liver ultrasound, enhanced CT, MRI, PET/CT, etc.), with no distant organ metastasis such as liver (M0) found; d) Have not received radiotherapy, chemotherapy, immunotherapy, surgery or other treatments.
- No history of other malignant tumors in the past.
- Signed informed consent.
Who cannot join
- Severe complications, such as liver and kidney dysfunction (Child-Pugh C or eGFR<30).
- Pregnant or lactating women.
- Those who cannot accept venipuncture, are afraid of needles and blood, or have difficulty in blood collection.
- Those who have donated blood (including blood products) or lost blood ≥200 mL in the past 2 months, or have received blood transfusions or used blood products in the past 2 months.
- Those who have participated in any clinical trials of drugs or medical devices in the past 3 months or those whose trial drugs have not exceeded 5 half-lives (whichever is longer).
- Unable to cooperate with follow-up (such as mental illness, expected survival <1 year).
- Withdrawal or loss of follow-up during the study.
- Incomplete information on study participants.
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
Huashan Hospital
Shanghai, Shanghai Municipality, 200000
Jie Liu, 02152888045, jieliu@fudan.edu.cn
About this study
Official title: Multicenter Clinical Validation of a Novel Strategy for Early Diagnosis and Recurrence Monitoring in Colorectal Cancer
Colorectal cancer (CRC) has an insidious onset and its survival rate is closely related to clinical stage. While the 5-year survival rate of stage I patients exceeds 90%, it drops to 14% in stage IV. In China, only 15.2% of CRC cases are diagnosed at stage I, far below the rate in developed countries like the United States (24.1%). Early detection and screening are key to reducing CRC mortality and improving patient outcomes. However, current screening methods-including colonoscopy, fecal immunochemical tests (FIT), and emerging stool or blood-based biomarkers-face limitations such as invasiveness, low sensitivity, high cost, or lack of large-scale clinical validation. Importantly, these methods fail to dynamically reflect tumor evolution or assess prognosis and treatment response.
Liquid biopsy has recently emerged as a promising non-invasive strategy for early cancer detection. It enables detection of tumor-related components in body fluids such as circulating tumor DNA (ctDNA), circulating tumor cells (CTCs), tumor-educated platelets (TEPs), exosomes, and cancer-specific proteins. These approaches offer a comprehensive view of tumor heterogeneity, epigenetic modifications, and treatment response. Our multidisciplinary team, from Fudan University, Xiamen University, and Xuzhou Medical University, has previously developed a cfDNA-5hmC-based diagnostic model using 5hmC-Seal technology, achieving 88% sensitivity and 89% specificity in detecting CRC.
Read more
To further improve tissue specificity and diagnostic accuracy, the investigators integrated multi-omics data and advanced AI techniques (including a Transformer-based deep learning model) to deconvolute tissue origin signals. In parallel, the investigators established a charge-selective CTC enrichment platform and discovered novel metabolic markers such as HPD that may indicate tumor recurrence and metastasis. The investigators team also developed a series of nano-biosensing platforms and tumor-targeting aptamer-based diagnostic kits, some of which have been granted national patents and clinical innovation awards.
This observational study will establish a large-scale, multi-center cohort of early-stage CRC patients. The investigators aim to construct a comprehensive multi-omics atlas from liquid biopsy samples, identify early diagnostic and prognostic biomarkers for CRC (including liver metastasis and drug resistance), and develop AI-driven models for non-invasive early detection and recurrence prediction. The study is expected to deliver clinically applicable technologies that improve CRC diagnostic accuracy, enable timely intervention, and reduce mortality. All study procedures will comply with ethical guidelines and be approved by institutional review boards.
- Conditions
- Colorectal Cancer
- Being tested
- Liquid biopsy
- Keywords
- Early diagnosis of colorectal cancer, Early warning of colorectal cancer recurrence, Liquid biopsy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liquid biopsyDiagnostic test
Serum protein profile, serum metabolic mass spectrometry, plasma cfDNA/cfRNA genomic and epigenomic assays, and serum tumor markers were performed. Patients were followed up for 3 years at a 3-month interval. Collect surgically removed colorectal cancer samples to construct PDX models if necessary.
| Study group | Role | What they receive |
|---|---|---|
| Early colorectal cancer | Not described Receives: Diagnostic Test: Liquid biopsy | |
| Control study participants with normal colonoscopy findings | Not described Receives: Diagnostic Test: Liquid biopsy | |
| Patients with non-neoplastic intestinal diseases | Not described Receives: Diagnostic Test: Liquid biopsy | |
| Patients with non-intestinal malignancies | Not described Receives: Diagnostic Test: Liquid biopsy | |
| Colorectal cancer resistant to chemotherapy | Not described Receives: Diagnostic Test: Liquid biopsy | |
| Patients with colorectal cancer liver metastasis | Not described Receives: Diagnostic Test: Liquid biopsy | |
| Colorectal cancer liver metastasis cohort control group | Not described Receives: Diagnostic Test: Liquid biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Performance of a Novel Liquid Biopsy Model Incorporating Multi-Omics (Proteomics, Metabolomics, Circulating Nucleic Acid Analysis) and Serum Tumor Markers for Detecting Early-Stage Colorectal Cancer
Measured: November, 2027
Diagnostic Performance of Novel Liquid Biopsy Model Incorporating Multi-Omics (Proteomics, Metabolomics, Circulating Nucleic Acid Analysis) and Serum Tumor Markers for prediction of CRC recurrence
Measured: November, 2027
Diagnostic Performance of Novel Liquid Biopsy Model Incorporating Multi-Omics (Proteomics, Metabolomics, Circulating Nucleic Acid Analysis) and Serum Tumor Markers for prediction of CRC resistant to chemotherapy
Measured: November, 2027
Diagnostic Performance of Novel Liquid Biopsy Model Incorporating Multi-Omics (Proteomics, Metabolomics, Circulating Nucleic Acid Analysis) and Serum Tumor Markers for prediction of CRC metastasis.
Measured: November, 2027
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2025
- Study startMay 2025 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Huashan HospitalThe 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
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jie Liu, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06991452
- Sponsor's protocol ID
- KY2025-627
- Status last verified
- May 2025
- First submitted
- 13 May 2025
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be publicly shared but may be made available to qualified researchers upon reasonable request, subject to data use agreements and ethics approval, in accordance with participant consent and institutional policies.
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Clinical Validation of a Novel Strategy for Early Diagnosis and Recurrence Monitoring in Colorectal Cancer
- ClinicalTrials.gov ID
- NCT06991452
- Acronym / sponsor ID
- KY2025-627
- Conditions
- Colorectal Cancer
- Keywords
- Early diagnosis of colorectal cancer, Early warning of colorectal cancer recurrence, Liquid biopsy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- May 2025 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 28 May 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.
Colorectal cancer (CRC) has an insidious onset and its survival rate is closely related to clinical stage. While the 5-year survival rate of stage I patients exceeds 90%, it drops to 14% in stage IV. In China, only 15.2% of CRC cases are diagnosed at stage I, far below the rate in developed countries like the United States (24.1%). Early detection and screening are key to reducing CRC mortality and improving patient outcomes. However, current screening methods-including colonoscopy, fecal immunochemical tests (FIT), and emerging stool or blood-based biomarkers-face limitations such as invasiveness, low sensitivity, high cost, or lack of large-scale clinical validation. Importantly, these methods fail to dynamically reflect tumor evolution or assess prognosis and treatment response.
Liquid biopsy has recently emerged as a promising non-invasive strategy for early cancer detection. It enables detection of tumor-related components in body fluids such as circulating tumor DNA (ctDNA), circulating tumor cells (CTCs), tumor-educated platelets (TEPs), exosomes, and cancer-specific proteins. These approaches offer a comprehensive view of tumor heterogeneity, epigenetic modifications, and treatment response. Our multidisciplinary team, from Fudan University, Xiamen University, and Xuzhou Medical University, has previously developed a cfDNA-5hmC-based diagnostic model using 5hmC-Seal technology, achieving 88% sensitivity and 89% specificity in detecting CRC.
To further improve tissue specificity and diagnostic accuracy, the investigators integrated multi-omics data and advanced AI techniques (including a Transformer-based deep learning model) to deconvolute tissue origin signals. In parallel, the investigators established a charge-selective CTC enrichment platform and discovered novel metabolic markers such as HPD that may indicate tumor recurrence and metastasis. The investigators team also developed a series of nano-biosensing platforms and tumor-targeting aptamer-based diagnostic kits, some of which have been granted national patents and clinical innovation awards.
This observational study will establish a large-scale, multi-center cohort of early-stage CRC patients. The investigators aim to construct a comprehensive multi-omics atlas from liquid biopsy samples, identify early diagnostic and prognostic biomarkers for CRC (including liver metastasis and drug resistance), and develop AI-driven models for non-invasive early detection and recurrence prediction. The study is expected to deliver clinically applicable technologies that improve CRC diagnostic accuracy, enable timely intervention, and reduce mortality. All study procedures will comply with ethical guidelines and be approved by institutional review boards.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Early colorectal cancer | – | Diagnostic Test: Liquid biopsy |
| Control study participants with normal colonoscopy findings | – | Diagnostic Test: Liquid biopsy |
| Patients with non-neoplastic intestinal diseases | – | Diagnostic Test: Liquid biopsy |
| Patients with non-intestinal malignancies | – | Diagnostic Test: Liquid biopsy |
| Colorectal cancer resistant to chemotherapy | – | Diagnostic Test: Liquid biopsy |
| Patients with colorectal cancer liver metastasis | – | Diagnostic Test: Liquid biopsy |
| Colorectal cancer liver metastasis cohort control group | – | Diagnostic Test: Liquid biopsy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study will recruit a multi-center cohort of colorectal cancer patients (all stages), individuals with precancerous lesions (e.g., adenomas), and healthy controls. Participants must be ≥18 years old and capable of providing informed consent. This diverse population will enable training and external validation of a non-invasive AI-based diagnostic and prognostic model.
Key inclusion criteria (43 listed)
- Aged between 18 and 80 years old, regardless of gender.
- Patients diagnosed with early colorectal cancer in our hospital, with the following specific criteria:
- No history of other malignant tumors.
- Sign the informed consent form.
- 2: Inclusion criteria for participants in the control study with no obvious abnormalities in colonoscopy:
Key exclusion criteria (8 listed)
- Severe complications, such as liver and kidney dysfunction (Child-Pugh C or eGFR<30).
- Pregnant or lactating women.
- Those who cannot accept venipuncture, are afraid of needles and blood, or have difficulty in blood collection.
- Those who have donated blood (including blood products) or lost blood ≥200 mL in the past 2 months, or have received blood transfusions or used blood products in the past 2 months.
- Those who have participated in any clinical trials of drugs or medical devices in the past 3 months or those whose trial drugs have not exceeded 5 half-lives (whichever is longer).
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 |
|---|---|---|
| Liquid biopsySerum protein profile, serum metabolic mass spectrometry, plasma cfDNA/cfRNA genomic and epigenomic assays, and serum tumor markers were performed. Patients were followed up for 3 years at a 3-month interval. Collect surgically removed colorectal cancer samples to construct PDX models if necessary. | Diagnostic test | Colorectal cancer liver metastasis cohort control group, Colorectal cancer resistant to chemotherapy, Control study participants with normal colonoscopy findings, Early colorectal cancer, Patients with colorectal cancer liver metastasis, Patients with non-intestinal malignancies, Patients with non-neoplastic intestinal diseases |
Primary outcome
Diagnostic Performance of a Novel Liquid Biopsy Model Incorporating Multi-Omics (Proteomics, Metabolomics, Circulating Nucleic Acid Analysis) and Serum Tumor Markers for Detecting Early-Stage Colorectal Cancer
Time frame: November, 2027
Diagnostic Performance of Novel Liquid Biopsy Model Incorporating Multi-Omics (Proteomics, Metabolomics, Circulating Nucleic Acid Analysis) and Serum Tumor Markers for prediction of CRC recurrence
Time frame: November, 2027
Diagnostic Performance of Novel Liquid Biopsy Model Incorporating Multi-Omics (Proteomics, Metabolomics, Circulating Nucleic Acid Analysis) and Serum Tumor Markers for prediction of CRC resistant to chemotherapy
Time frame: November, 2027
Diagnostic Performance of Novel Liquid Biopsy Model Incorporating Multi-Omics (Proteomics, Metabolomics, Circulating Nucleic Acid Analysis) and Serum Tumor Markers for prediction of CRC metastasis.
Time frame: November, 2027
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 28 May 2025.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be publicly shared but may be made available to qualified researchers upon reasonable request, subject to data use agreements and ethics approval, in accordance with participant consent and institutional policies.
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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.
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 Colorectal Cancer, run by Huashan Hospital 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 43 inclusion and 8 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: opening soon, as of the sponsor's last update on 28 May 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 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 Jie Liu, Dr. (862152888045, jieliu@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Performance of a Novel Liquid Biopsy Model Incorporating Multi-Omics (Proteomics, Metabolomics, Circulating Nucleic Acid Analysis) and Serum Tumor Markers for Detecting Early-Stage Colorectal Cancer (time frame: November, 2027). The study lists 4 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 28 May 2025.