Status:
ACTIVE_NOT_RECRUITING
Predictive Value of Postoperative Circulating Tumor DNA Monitoring for Colorectal Cancer Recurrence
Lead Sponsor:
Sun Yat-sen University
Collaborating Sponsors:
Guangzhou Burning Rock Dx Co., Ltd.
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18+ years
Brief Summary
This observational study aims to assess the predictive value of postoperative circulating tumor DNA (ctDNA) monitoring in evaluating the risk of recurrence in stage I-IV colorectal cancer patients. Th...
Eligibility Criteria
Inclusion
- Age ≥ 18 years at the time of signing the informed consent form.
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-1.
- Histologically confirmed colorectal cancer located from the ileocecal junction to the rectosigmoid junction, with a distance of \>15cm from the anal verge. Regardless of mismatch repair (MMR) status, Rat sarcoma (RAS) gene and proto-oncogene serine/threonine-protein kinase (RAF) gene status.
- Pathologically or cytologically confirmed American Joint Committee on Cancer (AJCC) tumor node metastasis (TNM) stage I-IV colorectal cancer patients (8th edition).
- No evidence of distant metastasis confirmed by comprehensive examination (no distant organ or lymph node metastasis).
- Normal organ function, as indicated by the following criteria:
- Hematology criteria: For patients who have not received blood transfusion, white blood cell (WBC) ≥ 3.5/4.0 × 10\^9/L, neutrophils ≥ 1.5 × 10\^9/L, platelet (PLT) ≥ 100 × 10\^9/L.
- Biochemistry criteria: Crea and bilirubin (BIL) ≤ 1.0 times the upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times ULN, alkaline phosphatase (ALP) ≤ 2.5 × ULN, total bilirubin (Tbil) ≤ 1.5 × ULN.
- Ability to provide clinical data required for the study.
- Sufficient tumor tissue available for analysis.
- Patients capable of achieving R0 radical resection.
- Patients capable of adhering to the planned schedule, actively participating in regular clinical follow-up, and necessary treatments.
Exclusion
- History of concurrent or prior malignancies (excluding adequately treated cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma of the skin).
- Patients who have received neoadjuvant therapy.
- Patients with other severe diseases that may affect follow-up and short-term survival, as determined by the investigator.
- Any other medical, social, or psychological conditions that, in the opinion of the investigator, would make the patient unsuitable for participation in this study.
- Inability to undergo clinical follow-up using contrast-enhanced magnetic resonance imaging (MRI) or contrast-enhanced computed tomography (CT).
Key Trial Info
Start Date :
January 15 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT06143644
Start Date
January 15 2022
End Date
June 30 2027
Last Update
December 4 2023
Active Locations (1)
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1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060