Exosome-based Detection of Molecular Residual Disease in Stage II-III Colorectal Cancer

Recruiting

• Conditions: Colo-rectal Cancer; Colorectal Cancer Recurrent

• Registration Number: NCT06654622
• Lead Sponsor: City of Hope Medical Center

Brief Summary

This study aims to establish an exosome-based liquid biopsy signature to detect molecular residual disease (MRD) in stage II-III colorectal cancer (CRC) patients. Identifying patients with MRD after surgery is crucial for selecting appropriate candidates for adjuvant chemotherapy (ACT), allowing for more personalized treatment approaches and potentially improving patient outcomes.

Detailed Description

The current standard for treating stage II-III colorectal cancer involves surgical resection, often followed by adjuvant chemotherapy (ACT) for high-risk patients. However, identifying patients who would benefit most from ACT remains challenging. Molecular residual disease (MRD) in these patients is a critical factor in determining the likelihood of recurrence. This study aims to develop an exosome-based liquid biopsy assay using circulating exosomal microRNAs (exo-miRNAs) to predict the presence of MRD in postoperative patients. By analyzing exo-miRNAs from blood samples collected after surgery, the goal is to identify high-risk patients who may benefit from ACT while sparing low-risk patients from unnecessary treatment. A risk-stratification model, termed the exosome-based molecular residual disease prediction for adjuvant chemotherapy induction (EMRATI) score, will be developed to improve ACT decision-making and enhance clinical outcomes for stage II-III CRC patients.

Study Timeline

• Study Start: 2023-04-01
• Study First Submitted: 2024-10-21
• Study First Submitted QC: 2024-10-21
• Study First Posted: 2024-10-23
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-28
• Last Update Posted: 2025-01-30
• Primary Completion: 2026-06-18
• Study Completion: 2026-06-18

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Patients with pathologically confirmed stage II or III colorectal cancer.
2. Patients who have undergone curative-intent surgery.
3. Patients with no evidence of distant metastasis (stage IV).
4. Patients aged 18 years or older.
5. Patients who provided written informed consent.

Exclusion Criteria

1. Patients with stage IV cancer or those receiving neoadjuvant therapy.
2. Patients with non-curative resection or requiring urgent surgery.
3. Patients with a follow-up period of fewer than 3 years.
4. Patients with severe comorbidities or who are unable to participate in follow-up assessments.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Tumor Evaluation (Recurrence)	Follow-up at regular intervals during the first 3 years post-surgery.	Assessment of tumor recurrence through clinical and imaging evaluations.

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS)	Patients will be monitored for overall survival for up to 5 years post-surgery.	Evaluation of the overall survival (OS) of patients, defined as the time from surgery to death from any cause.

Trial Locations

Locations (1)

City of Hope Medical Center; 🇺🇸 Duarte, California, United States