NCT06879873Not yet recruiting
MRD-Guided Surveillance in Operable Colon Adenocarcinoma (I-III)(SURVEILLANCE-I)
MRD-Guided Surveillance in Operable Colon Adenocarcinoma (I-III)
Source: ClinicalTrials.gov · Last updated 17 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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 of cancer cells that remain in the body after treatment but are undetectable by traditional imaging methods. The study will use a blood-based test to detect circulating tumor DNA (ctDNA) and assess its ability to predict cancer recurrence and survival outcomes. Patients who are newly diagnosed with stage I-III colon adenocarcinoma and are eligible for surgery will be enrolled. Blood samples will be collected at multiple time points, including before surgery, after surgery, and during follow-up visits over three years. The study will compare MRD status with recurrence-free survival (RFS), overall survival (OS), and the time it takes for MRD to detect recurrence compared to standard imaging methods. The goal is to determine whether MRD monitoring can provide early warning of cancer recurrence and help guide treatment decisions. This study may offer valuable insights into improving postoperative surveillance and personalized treatment strategies for colon cancer patients.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 390 (estimated)
- First submitted
- 11 Mar 2025
- Start date
- 1 Aug 2025
- Primary completion date
- 31 Jul 2027
- Lead sponsor
- Fudan University
- Diseases
- Colorectal cancer
- NCT number
- NCT06879873
What you commit to
- Study type: Observational
- Planned participants: 390
- From 1 Aug 2025 to the primary completion date, 31 Jul 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previously suffered from other malignant tumors (including non adenocarcinoma colorectal cancer);
Other illness
- According to the researchers' assessment, the patient also suffers from other diseases that may affect follow-up and short-term survival
Lab values
- 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.
Other
- Pregnant and lactating women;
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.