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Early Detection and Risk Stratification of Colorectal Cancer Based on miRNA Platform | Clinical Trials | Clareo Health

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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

NCT06351384•Sir Run Run Shaw Hospital

Summary

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•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
•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
•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.

Key Dates

Start Date

April 1, 2024

Primary Completion Date

October 1, 2025

Completion Date

December 31, 2025

Last Updated

April 8, 2024

Enrollment

600

ESTIMATED participants

Conditions

Colorectal Cancer

Interventions

miRNA detection test

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 8, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Early Detection and Risk Stratification of Colorectal Cancer Based on miRNA Platform

Inclusion Criteria

Exclusion Criteria

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