Clinical trial · Observational
MRD-Guided Surveillance in Operable Colon Adenocarcinoma (I-III)(SURVEILLANCE-I)
MRD-Guided Surveillance in Operable Colon Adenocarcinoma (I-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 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.
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 of I-III CRC
Primary outcomes (1)
- measure
- Exploring the correlation between MRD status and disease recurrence rate (RFS) in stage I-III operable colon adenocarcinoma
- timeFrame
- From surgery until disease recurrence or up to 36 months, whichever occurs first
- description
- Exploring the correlation between MRD status and disease recurrence rate (RFS) in stage I-III operable colon adenocarcinoma
Secondary outcomes (3)
- measure
- The correlation between MRD status and 1-year recurrence free survival (1yRFS)
- timeFrame
- From surgery until 12 months post-surgery
- description
- The correlation between MRD status and 1-year recurrence free survival (1yRFS)
- measure
- The correlation between MRD status and 2-year recurrence free survival (2yRFS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age range: 18-80 years old, male or female not limited; 2. Histologically confirmed colon adenocarcinoma (i.e. adenocarcinoma, including adenocarcinoma, mucinous adenocarcinoma, signet ring cell carcinoma, undifferentiated carcinoma; excluding adenosquamous cell carcinoma); 3. Preoperative staging of stages I-III, without undergoing endoscopic ESD or EMR surgical resection; 4. Not receiving chemotherapy, radiotherapy, targeted therapy, or other anti-tumor treatments; 5. Radical surgery can be performed; 6. ECOG score 0-1 points; 7. 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. Exclusion Criteria: 1. Previously suffered from other malignant tumors (including non adenocarcinoma colorectal cancer); 2. Pregnant and lactating women; 3. According to the researchers' assessment, the patient also suffers from other diseases that may affect follow-up and short-term survival 4. 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.
References
Publications (0)
Data not yet available