Detecting residual disease in colorectal cancer using exosomes

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 is trying to see if a blood test that looks for tiny particles called exosomes can help identify colorectal cancer patients who still have disease after surgery and might need additional treatment.

Quick facts

• Study type: Observational
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: City of Hope Medical Center (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Duarte, California)
• Trial ID: NCT06654622 on ClinicalTrials.gov

What this trial studies

This study aims to establish an exosome-based liquid biopsy signature to detect molecular residual disease (MRD) in patients with stage II-III colorectal cancer (CRC) after surgery. By analyzing circulating exosomal microRNAs (exo-miRNAs) from blood samples, the study seeks to identify high-risk patients who may benefit from adjuvant chemotherapy (ACT) while avoiding unnecessary treatment for low-risk patients. The goal is to develop a risk-stratification model, the exosome-based molecular residual disease prediction for adjuvant chemotherapy induction (EMRATI) score, to enhance decision-making regarding ACT and improve clinical outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 years or older with pathologically confirmed stage II or III colorectal cancer who have undergone curative-intent surgery.

Not a fit: Patients with stage IV cancer, those receiving neoadjuvant therapy, or those with severe comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more personalized treatment strategies for colorectal cancer patients, improving outcomes and reducing unnecessary chemotherapy.

How similar studies have performed: Other studies have shown promise in using liquid biopsies for cancer detection, but this specific approach using exosomal miRNAs is novel.

Eligibility criteria

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.

Where this trial is running

Duarte, California

• City of Hope Medical Center — Duarte, California, United States (RECRUITING)

Study contacts

• Principal investigator: Ajay Goel, PhD — City of Hope Medical Center
• Study coordinator: Takayuki Noma, MD

Conditions: Colo-rectal Cancer, Colorectal Cancer Recurrent, Colorectal cancer, Molecular residual disease, Adjuvant chemotherapy, Stage II-III CRC, exosomal miRNA