Liquid Biopsy for Early Detection of Colorectal Cancer Using Circular RNA

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT07224789
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • cf-circRNA assay — DIAGNOSTIC_TEST
    Circular RNA detection in plasma or serum by RT-qPCR

Study Details

Colorectal cancer (CRC) is a leading cause of cancer-related deaths worldwide. This study aims to develop a non-invasive liquid biopsy assay using plasma-derived cell-free circular RNAs (cf-circRNAs) for early and accurate detection of colorectal cancer.

Key Dates

Start date
Jan 15, 2025
Status verified
Nov 2025
Primary completion
Jun 18, 2026
Completion
Jun 18, 2026

Study Design

Enrollment
600 participants (estimated)

Arms

  • Arm: Colorectal Cancer - Training Cohort
    Patients with histologically confirmed colorectal adenocarcinoma (Stage I-III) enrolled in the training set. Plasma samples are collected before any surgery or therapy for cf-circRNA profiling.
  • Arm: Non-Disease Control - Training Cohort
    Healthy individuals with no prior malignancy or major systemic disease, age- and sex-matched to the CRC group, included in the training set.
  • Arm: Colorectal Cancer - Validation Cohort
    Independent cohort of patients with histologically confirmed colorectal adenocarcinoma (Stage I-III) from separate institutions, used to validate the diagnostic cf-circRNA signature. Plasma obtained prior to treatment.
  • Arm: Non-Disease Control - Validation Cohort
    Independent cohort of healthy participants without malignant or inflammatory bowel disease, serving as external validation controls.

Primary Outcome Measure

Sensitivity [ Time Frame: Through study completion, an average of 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91016
Ajay Goel, PhD
626-218-3452

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