Metabolic biomarker development for early diagnosis, prognosis, and recurrence prediction in colorectal cancer

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

We will test whether specific metabolic markers in blood and tumor tissue can help detect colorectal cancer earlier, predict outcomes, and spot recurrence in adults.

Quick facts

• Study type: Observational
• Enrollment: 250 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shanghai Minimally Invasive Surgery Center (Academic / other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT07068529 on ClinicalTrials.gov

What this trial studies

This is a prospective observational effort to build a metabolite database for colorectal cancer using metabolomics technology. The project will collect tumor tissue and peripheral blood from treatment‑naïve colorectal cancer patients and blood from healthy adult controls, then profile metabolites to identify candidate biomarkers. Identified markers will be validated for their ability to indicate early disease, predict prognosis, and signal risk of recurrence or metastasis. No experimental treatments are given; the focus is sample collection, laboratory analysis, and clinical correlation.

Who should consider this trial

Good fit: Ideal participants are adults (≥18) with histologically confirmed, treatment‑naïve colorectal adenocarcinoma and ECOG ≤1 who can provide required tumor tissue and blood samples, as well as healthy adult controls without hereditary colorectal cancer risk.

Not a fit: Patients who have already received anti-tumor treatment, have hereditary colorectal cancer syndromes, poor performance status, or cannot provide required samples are unlikely to benefit from this observational biomarker project.

Why it matters

Potential benefit: If successful, this work may yield a safe, convenient blood- or tissue-based test that enables earlier detection and better prediction of outcomes and recurrence for colorectal cancer patients.

How similar studies have performed: Previous metabolomics studies have identified promising candidate biomarkers for colorectal cancer diagnosis and prognosis, but large-scale, clinically validated tests remain limited.

Eligibility criteria

Inclusion Criteria:

* \*\*Healthy Controls:\*\*

  1. Age ≥ 18 years;
  2. Signed informed consent and willingness to participate in the project.

\*\*Colorectal Cancer:\*\*

1. Age ≥ 18 years;
2. Performance status (ECOG) score ≤ 1;
3. Histopathologically confirmed colorectal adenocarcinoma;
4. No family history of hereditary cancer;
5. No prior anti-tumor treatment;
6. Availability of primary tumor tissue from surgery or biopsy that meets submission requirements;
7. Availability of peripheral blood samples that meet submission requirements;
8. Willingness and ability to sign the informed consent form to participate in the study.

Exclusion Criteria:

* \*\*Healthy Controls:\*\*

  1. 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);
  2. History of chronic metabolic or inflammatory diseases that are difficult to control, such as hypertension, diabetes, chronic viral hepatitis, and inflammatory bowel disease;
  3. 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;
  4. History of oral or intravenous use of broad-spectrum antibiotics and probiotics within the past month;
  5. Regular use of immunosuppressive drugs within the past 6 months;
  6. Long-term use of other medications that may affect metabolism, such as hormones;
  7. Inability or unwillingness to cooperate with follow-up visits and related examinations;
  8. Inability to eat normally or requiring medications or enemas for bowel movements;
  9. Presence of psychiatric disorders or other severe cardiovascular diseases;
  10. Pregnant, breastfeeding, or planning to become pregnant within the next year;
  11. Currently participating in an interventional clinical study or receiving study treatment that may influence the patient's treatment decision.

\*\*Colorectal Cancer:\*\*

1. A clear family history of hereditary colorectal cancer, such as Lynch syndrome, familial adenomatous polyposis, Peutz-Jeghers syndrome, etc.;
2. Currently participating in an interventional clinical study or receiving study treatment that may influence the patient's treatment decision;
3. 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;
4. History of chronic metabolic or inflammatory diseases that are difficult to control, such as hypertension, diabetes, chronic viral hepatitis, and inflammatory bowel disease;
5. Presence of poorly controlled chronic comorbidities that may affect prognosis;
6. Presence of psychiatric disorders or other severe cardiovascular diseases;
7. Pregnant, breastfeeding, or planning to become pregnant within the next year;
8. Long-term use of medications that may affect metabolism, such as hormones, immunosuppressants, antibiotics, etc.;
9. Any severe and/or uncontrolled medical conditions, as judged by the investigator, that may affect the patient's ability to participate in the study or interfere with study results.

Where this trial is running

Shanghai, Shanghai Municipality

• Ruijin hospital Shanghai Jiaotong University, School of Medicine — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Jing Sun

Conditions Colorectal Cancer; Metabolic Marker; Prognosis; Early Diagnosis