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

March 11, 2026 updated by: City of Hope Medical Center

An Exosome-Based Liquid Biopsy Assay to Detect Molecular Residual Disease for the Identification of High-Risk Patients With Stage II-III Colorectal Cancer

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

175

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Duarte, California, United States, 91010
        • City of Hope Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

The study will enroll patients with stage II-III colorectal cancer who have undergone curative surgery and require assessment for molecular residual disease to determine whether adjuvant chemotherapy is necessary.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Training Cohort (Recurrence Group)
Stage II-III CRC patients who experienced postoperative recurrence (evaluated by miRNA panel).
Training Cohort (Non-Recurrence Group)
Stage II-III CRC patients who did not experience postoperative recurrence (evaluated by miRNA panel).
Testing Cohort (Recurrence Group)
Validation of miRNA panel and EMRATI score in independent stage II-III CRC patients who experienced postoperative recurrence.
Testing Cohort (Non-Recurrence Group)
Validation of miRNA panel and EMRATI score in independent stage II-III CRC patients who did not experience postoperative recurrence.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: 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.
Patients will be monitored for overall survival for up to 5 years post-surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

City of Hope Medical Center

Investigators

  • Principal Investigator: Ajay Goel, PhD, City of Hope Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2023

Primary Completion (Actual)

January 18, 2026

Study Completion (Actual)

February 18, 2026

Study Registration Dates

First Submitted

October 21, 2024

First Submitted That Met QC Criteria

October 21, 2024

First Posted (Actual)

October 23, 2024

Study Record Updates

Last Update Posted (Actual)

March 13, 2026

Last Update Submitted That Met QC Criteria

March 11, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23228/CRMRD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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