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

Colorectal Cancer Clinical Trial

Official title:

Early Detection and Risk Stratification of Colorectal Cancer Based on miRNA Platform: a Prospective, Pilot Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06351384
• Other study ID #: 20230744
• Status: Not yet recruiting
• Start date: April 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: Sir Run Run Shaw Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 600
• Est. completion date: December 31, 2025
• Est. primary completion date: October 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Device:
• miRNA detection test
miRNA sequencing based on Next-Generation Sequencing (NGS) technology

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sir Run Run Shaw Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between post-surgery 1 month MRD status and recurrence-free survival (RFS) in colorectal patients		24 months