NCT06879886Not yet recruiting
MRD-Guided Surveillance in Resectable Stage IV Metastatic Colorectal Cancer (SURVEILLANCE-II)
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 resectable stage IV metastatic colorectal cancer (mCRC). 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 circulating tumor DNA (ctDNA) methylation test to assess its ability to predict cancer recurrence and survival outcomes. Patients who are newly diagnosed with resectable stage IV mCRC and have not yet received any treatment will be enrolled. Blood samples will be collected at multiple time points, including before surgery, after surgery, and during follow-up visits over two 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 an 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 metastatic colorectal cancer patients.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 181 (estimated)
- First submitted
- 11 Mar 2025
- Start date
- 1 Aug 2025
- Primary completion date
- 31 Mar 2027
- Lead sponsor
- Fudan University
- Diseases
- Colorectal cancer
- NCT number
- NCT06879886
What you commit to
- Study type: Observational
- Planned participants: 181
- From 1 Aug 2025 to the primary completion date, 31 Mar 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
- Patients with other concurrent illnesses that, in the judgment of the investigator, may interfere with follow-up and short-term survival;
Other illness
- Previous other malignant tumors (including non-adenocarcinoma colorectal cancer);
Lab values
- The subject has other factors that may cause this study to be forced to be terminated halfway, such as other serious illnesses (including psychiatric illnesses) that require comorbid treatment, serious laboratory test abnormalities, accompanied by family or social factors that would affect the safety of the subject, or the collection of data and samples.
Other
- Pregnant and lactating women;
Who the study is looking for
- Age 18-80 years old, male or female;
- histologically confirmed primary foci of colorectal adenocarcinoma (i.e., adenoepithelial carcinoma, including adenocarcinoma, mucinous adenocarcinoma, imprinted cell carcinoma, and undifferentiated carcinoma; excluding adenosquamous carcinoma); (3) Preoperative stage IV and no surgical resection; (4) Not receiving chemotherapy, radiotherapy, targeted therapy or other anti-tumor therapy;
- 5\) Surgical resection of primary/metastatic foci is possible; 6) ECOG score 0-1; 7) Subjects voluntarily enrolled in the study and signed the informed consent, good compliance, and actively cooperate with the regular clinical follow-up clinic back in the hospital.
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.