Clinical trial · Observational
MRD-Guided Surveillance in Locally Advanced Mid-Low Rectal Cancer (SURVEILLANCE-III)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study aims to explore the relationship between minimal residual disease (MRD) status and disease recurrence in patients with locally advanced mid-low rectal cancer. 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 cT3/N+, M0 mid-low rectal cancer (tumor ≤10 cm from the anal verge) and are eligible for curative-intent treatment will be enrolled. Blood samples will be collected at multiple time points, including before neoadjuvant therapy, before surgery, after surgery, and during follow-up visits over three years. The study will compare MRD status with disease-free survival (DFS), 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 rectal cancer patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer (CRC) | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- MRD-Guided Surveillance in Locally Advanced Mid-Low Rectal Cancer
Primary outcomes (1)
- measure
- Exploring the correlation between MRD status and disease-free survival (DFS) in patients with locally progressive low and intermediate rectal cancer
- timeFrame
- From surgery to disease recurrence or up to 36 months
- description
- Exploring the correlation between MRD status and disease-free survival (DFS) in patients with locally progressive low and intermediate rectal cancer
Secondary outcomes (3)
- measure
- Correlation of MRD status with 1-year recurrence-free survival (1yRFS)
- timeFrame
- From surgery to 12 months
- description
- Correlation of MRD status with 1-year recurrence-free survival (1yRFS)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1) Age 18-80 years old, male or female; 2) histologically confirmed diagnosis of rectal adenocarcinoma (i.e., adenoepithelial carcinoma, including adenocarcinoma, mucinous carcinoma, imprinted cell carcinoma, and undifferentiated carcinoma; excluding adenosquamous carcinoma); 3) Preoperative clinical stage cT3 /N+, M0, the lower edge of the tumor is ≤10cm from the anal verge, and no surgical resection is performed; (4) Not receiving chemotherapy, radiotherapy, targeted therapy or other anti-tumor therapy; 5) Radical surgery is available; 6) ECOG score 0-1; 7) Subjects voluntarily enrolled in this study and signed the informed consent, good compliance, follow the planned schedule and actively cooperate with the return to the hospital for regular clinical follow-up and necessary treatment. Exclusion Criteria: 1. previous other malignant tumors (including non-adenocarcinoma colorectal cancer); 2. Previously received other anti-tumor therapy; 3. Pregnant and lactating women; (4) Patients with other medical conditions that, in the judgment of the investigator, may interfere with follow-up and short-term survival; 5\) Subjects have other factors that may lead to forced termination of this study, such as other serious illnesses (including mental illness, infectious diseases, fever ≥38℃, etc.) that require combined treatment, serious laboratory test abnormalities, accompanied by family or social factors that will affect the safety of the subjects, or the collection of data and samples.
References
Publications (0)
Data not yet available