Recruiting

Liquid Biopsy

Sponsor:

City of Hope Medical Center

Code:

NCT07224789

Conditions

Colorectal Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

cf-circRNA assay

Study Details

Brief summary:

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.

Conditions

Colorectal Cancer

Study ID

NCT07224789

Start date

Jan 15, 2025

Status verified date

Jul, 2026

Completion date

Jun 18, 2028

Anticipated

Primary completion date

Jun 18, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Adults (≥18 years old)
  • Histologically confirmed colorectal cancer (Stage I-III)
  • Availability of pre-treatment plasma samples
  • Written informed consent provided

Exclusion Criteria:

  • History of other active malignancies within the past 5 years
  • Poor sample quality or hemolysis
  • Inability to provide informed consent

Study Design

Enrollment

600 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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.

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.

Non-Disease Control - Validation Cohort

Independent cohort of healthy participants without malignant or inflammatory bowel disease, serving as external validation controls.

Interventions

cf-circRNA assay

Circular RNA detection in plasma or serum by RT-qPCR

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Goel Ajay, PhD

626-218-3452ajgoel@coh.org

Locations

City of Hope Medical Center

Recruiting

Duarte, California, United States, 91016

Contacts

Ajay Goel, PhD

626-218-3452ajgoel@coh.org

More Information

Sponsor

City of Hope Medical Center

Last update posted

Jul 7, 2026

Last verified

Jul, 2026

Keywords

  • circRNA
  • Early cancer detection
  • non-coding RNA
  • CRC
  • liquid biopsy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by City of Hope Medical Center on 2026-07-07.