Clinical trial · Observational
Early Detection and Risk Stratification of Colorectal Cancer Based on miRNA Platform
Early Detection and Risk Stratification of Colorectal Cancer Based on miRNA Platform: a Prospective, Pilot Study
- 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 is a prospective, observational cohort study to establish the minimal residual disease (MRD) model for predicting relapse risk and identifying disease recurrence in patients with colorectal adenocarcinoma based on the miRNA platform. Blood miRNA markers will be evaluated. The study will enroll approximately 600 participants, including participants with malignancies or benign diseases, and healthy participants.
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 | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| miRNA detection test | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Colorectal cancer arm
- interventionNames
- Device: miRNA detection test
- label
- Healthy control arm
- interventionNames
- Device: miRNA detection test
- label
- Intestinal polyp arm
- interventionNames
- Device: miRNA detection test
Primary outcomes (1)
- measure
- Correlation between post-surgery 1 month MRD status and recurrence-free survival (RFS) in colorectal patients
- timeFrame
- 24 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: Inclusion Criteria for the colorectal cancer arm: 1.18-75 years old 2. Pathologically confirmed as colorectal adenocarcinoma 3. Medically able to receive radical surgery for colorectal cancer 4. Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 to 1 5. Ability to provide a written informed consent Inclusion Criteria for the healthy control arm: 1.18-75 years old 2. No clinically significant finding based on routine blood tests, urinalysis, CT, and ultrasound examinations 3. Ability to provide a written informed consent Inclusion Criteria for the intestinal polyp arm: 1.18-75 years old 2. Pathologically confirmed as colorectal adenoma 3. Ability to provide a written informed consent Exclusion Criteria: 1. History of other malignant tumors (excluding non-melanoma skin cancer). 2. Prior or related treatments previously (including colorectal cancer or advanced adenoma surgery, endoscopic treatment, chemotherapy, targeted therapy, immunotherapy, radiation, neoadjuvant therapy, etc.). 3. Patients with hereditary colorectal diseases (including Lynch syndrome, familial CRC type X (FCCX), familial adenomatous polyposis (FAP), MUTHY-associated polyposis (MAP), Peutz-Jeghers syndrome (PJS), juvenile polyposis syndrome (JPS), serrated polyposis syndrome (SPS), etc.). 4. Usage of anti-tumor drugs such as methotrexate, cyclophosphamide, mercaptopurine, and bendamustine for other diseases within 30 days before blood collection. 5. Prior blood transfusion (including blood components) within the past 2 weeks. 6. Prior organ transplantation, bone marrow transplantation, or stem cell transplantation. 7. Pregnancy women. 8. Acute inflammation or fever requiring drug escalation within 14 days prior to blood collection. 9. Inability to comply with study procedures such as blood collection and related examinations. 10. Deemed unsuitable for participation in the clinical trial by the investigator.
References
Publications (0)
Data not yet available