NCT07795528 Postoperative Circulating Tumor DNA Monitoring in Stage I-III Driver-Mutant Colon Adenocarcinoma
| NCT ID | NCT07795528 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ruijin Hospital |
| Condition | Colon Adenocarcinoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 392 participants |
| Start Date | 2026-08-14 |
| Primary Completion | 2030-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 392 participants in total. It began in 2026-08-14 with a primary completion date of 2030-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This multicenter prospective observational cohort study will enroll 392 patients with stage I-III colon adenocarcinoma who undergo curative resection and whose tumors harbor at least one prespecified oncogenic driver mutation (KRAS, NRAS, BRAF, or PIK3CA). Serial plasma circulating tumor DNA (ctDNA) testing for molecular residual disease (MRD) will be performed with a standardized 10-gene next-generation sequencing (NGS) panel at predefined time points during 3 years of postoperative follow-up. The primary objective is to evaluate the association between postoperative ctDNA-based MRD status and recurrence-free survival (RFS). Secondary objectives include evaluating overall survival (OS), the interval between first MRD detection and radiologically confirmed recurrence, and the association between longitudinal MRD changes and outcomes following adjuvant chemotherapy.
Eligibility Criteria
Inclusion Criteria: 1. Age 18-75 years, regardless of sex 2. Pathologically confirmed colon adenocarcinoma, clinical stage I-III without preoperative endoscopic submucosal dissection (ESD) or endoscopic mucosal resection (EMR) 3. Planned curative surgical resection, no prior anti-tumor therapy (chemotherapy, radiotherapy, targeted therapy) before surgery 4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 5. Tumor tissue positive for at least one driver mutation among KRAS, NRAS, BRAF, PIK3CA 6. Voluntary participation with signed written informed consent, good compliance with scheduled follow-up and blood collection. Exclusion Criteria: 1. Received neoadjuvant chemotherapy, radiotherapy or targeted therapy before surgery 2. History of other malignant tumors (excluding non-adenomatous colorectal neoplasms) 3. Pregnant or breastfeeding women 4. Severe concurrent systemic diseases that interfere with long-term follow-up or short-term survival (uncontrolled severe infection, organ failure, mental disorders, or other serious conditions) 5. Abnormal laboratory values or social/family factors judged by investigator to impede sample collection and follow-up 6. Simultaneous participation in other interventional clinical trials with mandatory assigned postoperative treatment regimen
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07795528 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Colon Adenocarcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07795528 currently recruiting?
Yes, NCT07795528 is actively recruiting participants. Contact the research team at zhaorensurgeon@aliyun.com for enrollment information.
Where is the NCT07795528 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07795528 clinical trial?
NCT07795528 is sponsored by Ruijin Hospital. The trial plans to enroll 392 participants.