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

NCT06351384 | Not Yet Recruiting

• 1 other identifier: 20230744
• Study Type: observational
• Target: 600
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Correlation between post-surgery 1 month MRD status and recurrence-free survival (RFS) in colorectal patients

  24 months

Study Arms (3)

Colorectal cancer arm

Device: miRNA detection test

Healthy control arm

Device: miRNA detection test

Intestinal polyp arm

Device: miRNA detection test

Interventions

miRNA detection test DEVICE

miRNA sequencing based on Next-Generation Sequencing (NGS) technology

Colorectal cancer arm; Healthy control arm; Intestinal polyp arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Eligible participants will be recruited from medical centers and assigned into three arms, including participants with new diagnosis of colorectal adenocarcinoma, participants with intestinal polyp, and healthy control.

You may qualify if:

• 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
• 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
• years old 2. Pathologically confirmed as colorectal adenoma 3. Ability to provide a written informed consent

You may not qualify if:

• History of other malignant tumors (excluding non-melanoma skin cancer).
• Prior or related treatments previously (including colorectal cancer or advanced adenoma surgery, endoscopic treatment, chemotherapy, targeted therapy, immunotherapy, radiation, neoadjuvant therapy, etc.).
• 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.).
• Usage of anti-tumor drugs such as methotrexate, cyclophosphamide, mercaptopurine, and bendamustine for other diseases within 30 days before blood collection.
• Prior blood transfusion (including blood components) within the past 2 weeks.
• Prior organ transplantation, bone marrow transplantation, or stem cell transplantation.
• Pregnancy women.
• Acute inflammation or fever requiring drug escalation within 14 days prior to blood collection.
• Inability to comply with study procedures such as blood collection and related examinations.
• Deemed unsuitable for participation in the clinical trial by the investigator.

Sponsors & Collaborators

• Sir Run Run Shaw Hospital: lead

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral Blood

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2024
• First Posted: April 8, 2024
• Study Start: April 1, 2024
• Primary Completion: October 1, 2025
• Study Completion: December 31, 2025
• Last Updated: April 8, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share