Development and Validation of Metabolic Biomarkers for Early Diagnosis, Prognosis, and Recurrence of Colorectal Cancer：MetBio-CRC

NCT07068529 | Recruiting DMC

• 1 other identifier: MetBio-CRC
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective clinical observational study aims to construct a metabolite database specifically for colorectal cancer patients using metabolomics technology. It seeks to develop and validate metabolic biomarkers for early diagnosis, prognosis, and prediction of recurrence and metastasis in colorectal cancer, thereby a establishing safe, convenient, and highly sensitive method for early screening and prognostic prediction.

Conditions

Colorectal Cancer

Keywords

Colorectal Cancer; Metabolic Marker; Prognosis; Early Diagnosis

Outcome Measures

Primary Outcomes (2)

• Overall survival

  The time from the start of treatment to death due to any cause.

  3 years

• Disease-Free Survival

  Disease-Free Survival (DFS) refers to the length of time after primary treatment for a disease during which the patient remains free of certain signs or symptoms of the disease. It is typically measured from the start of treatment until the first recurrence or relapse of the disease.

  3 years

Secondary Outcomes (7)

• Hazard Ratio

  3 years

• Positive Predictive Value

  3 years

• Negative Predictive Value

  3 years

• Assessment of Important Metabolic Biomarkers

  3 years

• Recurrence and Metastasis Rate

  3 years

Study Arms (2)

Baseline

This group recruits healthy individuals which is intended to establish a metabolic biomarker baseline

CRC

Colorectal cancer group, which is study of interest

Eligibility Criteria

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

Study Population

Patients with colorectal cancer and healthy individuals.

You may qualify if:

• \*\*Healthy Controls:\*\*
• Age ≥ 18 years;
• Signed informed consent and willingness to participate in the project.
• \*\*Colorectal Cancer:\*\*
• Age ≥ 18 years;
• Performance status (ECOG) score ≤ 1;
• Histopathologically confirmed colorectal adenocarcinoma;
• No family history of hereditary cancer;
• No prior anti-tumor treatment;
• Availability of primary tumor tissue from surgery or biopsy that meets submission requirements;
• Availability of peripheral blood samples that meet submission requirements;
• Willingness and ability to sign the informed consent form to participate in the study.

You may not qualify if:

• \*\*Healthy Controls:\*\*
• Individuals at high risk for hereditary colorectal adenocarcinoma, including family members of the following diseases: family history of gastrointestinal tumors, familial adenomatous polyposis (FAP), hereditary nonpolyposis colorectal cancer (HNPCC/LS), and Peutz-Jeghers syndrome (P-J syndrome);
• History of chronic metabolic or inflammatory diseases that are difficult to control, such as hypertension, diabetes, chronic viral hepatitis, and inflammatory bowel disease;
• Known history of other malignancies that have progressed or required treatment within the past 5 years, except for skin basal cell carcinoma and squamous cell carcinoma that have been cured;
• History of oral or intravenous use of broad-spectrum antibiotics and probiotics within the past month;
• Regular use of immunosuppressive drugs within the past 6 months;
• Long-term use of other medications that may affect metabolism, such as hormones;
• Inability or unwillingness to cooperate with follow-up visits and related examinations;
• Inability to eat normally or requiring medications or enemas for bowel movements;
• Presence of psychiatric disorders or other severe cardiovascular diseases;
• Pregnant, breastfeeding, or planning to become pregnant within the next year;
• Currently participating in an interventional clinical study or receiving study treatment that may influence the patient's treatment decision.
• \*\*Colorectal Cancer:\*\*
• A clear family history of hereditary colorectal cancer, such as Lynch syndrome, familial adenomatous polyposis, Peutz-Jeghers syndrome, etc.;
• Currently participating in an interventional clinical study or receiving study treatment that may influence the patient's treatment decision;

Sponsors & Collaborators

• Shanghai Minimally Invasive Surgery Center: lead

Study Sites (1)

Ruijin hospital Shanghai Jiaotong University, School of Medicine

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Peripheral blood samples and tumor tissue samples are collected accordingly.

MeSH Terms

Conditions

Colorectal Neoplasms; Disease

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; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jing Sun

CONTACT

+86-13524284622; sj117788@rjh.com.cn

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2025
• First Posted: July 16, 2025
• Study Start: June 15, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2030
• Last Updated: July 16, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)