Early Diagnosis and Recurrence Monitoring of Colorectal Cancer

NCT06991452 | Not Yet Recruiting

• 1 other identifier: KY2025-627
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Colorectal Cancer

Keywords

Early diagnosis of colorectal cancer; Early warning of colorectal cancer recurrence; Liquid biopsy

Outcome Measures

Primary Outcomes (4)

• 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

  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

  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

  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.

  November, 2027

Study Arms (7)

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

Interventions

Liquid biopsy DIAGNOSTIC_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.

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.
• No history of other malignant tumors.
• Sign the informed consent form.
• 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.
• 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.
• Aged between 18 and 80 years old, regardless of gender.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Huashan Hospital: lead

Study Sites (1)

Huashan Hospital

Shanghai, Shanghai Municipality, 200000, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Liquid Biopsy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Investigative Techniques

Central Study Contacts

Jie Liu, Dr.

CONTACT

862152888045; jieliu@fudan.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: May 28, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)