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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06654622

Enrollment

175

Registered

2024-10-23

Start date

2023-04-01

Completion date

2026-02-18

Last updated

2026-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colo-rectal Cancer, Colorectal Cancer Recurrent

Keywords

Colorectal cancer, Molecular residual disease, Adjuvant chemotherapy, Stage II-III CRC, exosomal miRNA

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORAjay Goel, PhD

City of Hope Medical Center

Outcome results