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

NCT ID: NCT06351384

Last Updated: 2024-04-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 600 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2025-12-31

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Colorectal cancer arm

miRNA detection test

Intervention Type: DEVICE

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

Healthy control arm

miRNA detection test

Intervention Type: DEVICE

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

Intestinal polyp arm

miRNA detection test

Intervention Type: DEVICE

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

Interventions

miRNA detection test

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sir Run Run Shaw Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

20230744

Identifier Type: -

Identifier Source: org_study_id