Status:
NOT_YET_RECRUITING
MRD-Guided Surveillance in Operable Colon Adenocarcinoma (I-III)(SURVEILLANCE-I)
Lead Sponsor:
Fudan University
Conditions:
Colorectal Cancer (CRC)
Eligibility:
All Genders
18-80 years
Brief Summary
This study aims to explore the relationship between minimal residual disease (MRD) status and disease recurrence in patients with stage I-III operable colon adenocarcinoma. MRD refers to the presence ...
Detailed Description
This is a multicenter, prospective, observational study designed to evaluate the effectiveness of ctDNA-based MRD monitoring in predicting disease recurrence and survival outcomes in patients with sta...
Eligibility Criteria
Inclusion
- Age range: 18-80 years old, male or female not limited;
- Histologically confirmed colon adenocarcinoma (i.e. adenocarcinoma, including adenocarcinoma, mucinous adenocarcinoma, signet ring cell carcinoma, undifferentiated carcinoma; excluding adenosquamous cell carcinoma);
- Preoperative staging of stages I-III, without undergoing endoscopic ESD or EMR surgical resection;
- Not receiving chemotherapy, radiotherapy, targeted therapy, or other anti-tumor treatments;
- Radical surgery can be performed;
- ECOG score 0-1 points;
- The subjects voluntarily joined this study and signed an informed consent form, demonstrating good compliance and actively cooperating to return to the hospital for regular clinical follow-up diagnosis and treatment.
Exclusion
- Previously suffered from other malignant tumors (including non adenocarcinoma colorectal cancer);
- Pregnant and lactating women;
- According to the researchers' assessment, the patient also suffers from other diseases that may affect follow-up and short-term survival
- Subjects have other factors that may lead to the forced termination of this study, such as other serious diseases (including mental illness, infectious diseases, fever ≥ 38 ℃, etc.) requiring combined treatment, serious laboratory examination abnormalities, accompanied by family or social factors, which will affect the safety of subjects, or the collection of data and samples.
Key Trial Info
Start Date :
August 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 31 2029
Estimated Enrollment :
390 Patients enrolled
Trial Details
Trial ID
NCT06879873
Start Date
August 1 2025
End Date
July 31 2029
Last Update
March 17 2025
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