Actively Recruiting
Development and Validation of Metabolic Biomarkers for Early Diagnosis, Prognosis, and Recurrence of Colorectal Cancer：MetBio-CRC
Led by Shanghai Minimally Invasive Surgery Center · Updated on 2025-07-16
250
Participants Needed
1
Research Sites
263 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Development and Validation of Metabolic Biomarkers for Early Diagnosis, Prognosis, and Recurrence of Colorectal Cancer：MetBio-CRC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy controls must be aged 18 years or older.
- Healthy controls must sign informed consent and agree to participate.
- Colorectal cancer patients must be aged 18 years or older.
- Colorectal cancer patients must have a performance status (ECOG) score of 1 or less.
- Colorectal cancer patients must have histopathologically confirmed colorectal adenocarcinoma.
- Colorectal cancer patients must have no family history of hereditary cancer.
- Colorectal cancer patients must not have received prior anti-tumor treatment.
- Colorectal cancer patients must have primary tumor tissue from surgery or biopsy that meets submission requirements.
- Colorectal cancer patients must have peripheral blood samples that meet submission requirements.
- Colorectal cancer patients must be willing and able to sign informed consent to participate.
You will not qualify if you...
- Healthy controls with high risk for hereditary colorectal adenocarcinoma or family history of specific gastrointestinal tumors and syndromes are excluded.
- Healthy controls with chronic metabolic or inflammatory diseases that are difficult to control, such as hypertension, diabetes, chronic viral hepatitis, or inflammatory bowel disease, are excluded.
- Healthy controls with history of other malignancies that progressed or required treatment within the past 5 years, except cured skin basal or squamous cell carcinoma, are excluded.
- Healthy controls who used broad-spectrum antibiotics or probiotics orally or intravenously within the past month are excluded.
- Healthy controls with regular use of immunosuppressive drugs within the past 6 months are excluded.
- Healthy controls with long-term use of medications that may affect metabolism, such as hormones, are excluded.
- Healthy controls unwilling or unable to cooperate with follow-up visits and examinations are excluded.
- Healthy controls unable to eat normally or requiring medications or enemas for bowel movements are excluded.
- Healthy controls with psychiatric disorders or severe cardiovascular diseases are excluded.
- Healthy controls who are pregnant, breastfeeding, or planning pregnancy within the next year are excluded.
- Healthy controls currently in interventional clinical studies or receiving study treatments influencing treatment decisions are excluded.
- Colorectal cancer patients with clear family history of hereditary colorectal cancer syndromes are excluded.
- Colorectal cancer patients currently in interventional clinical studies or receiving study treatments influencing treatment decisions are excluded.
- Colorectal cancer patients with history of other malignancies that progressed or required treatment within past 5 years, except cured skin basal or squamous cell carcinoma, are excluded.
- Colorectal cancer patients with chronic metabolic or inflammatory diseases difficult to control are excluded.
- Colorectal cancer patients with poorly controlled chronic comorbidities affecting prognosis are excluded.
- Colorectal cancer patients with psychiatric disorders or severe cardiovascular diseases are excluded.
- Colorectal cancer patients who are pregnant, breastfeeding, or planning pregnancy within the next year are excluded.
- Colorectal cancer patients with long-term use of medications affecting metabolism, such as hormones, immunosuppressants, or antibiotics, are excluded.
- Colorectal cancer patients with any severe or uncontrolled medical conditions that may affect participation or study results are excluded.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Ruijin hospital Shanghai Jiaotong University, School of Medicine
Shanghai, Shanghai Municipality, China, 200025
Actively Recruiting
Research Team
J
Jing Sun
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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