Liquid Biopsy for Early Detection of Colorectal Cancer Using Circular RNA
Purpose
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.
Condition
- Colorectal Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- Phase
- Study Type
- Observational
- Observational Model
- Case-Control
- Time Perspective
- Retrospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| 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. |
|
Recruiting Locations
Duarte, California 91016
More Details
- Status
- Recruiting
- Sponsor
- City of Hope Medical Center
Detailed Description
Colorectal cancer (CRC) is the third most common malignancy and the second leading cause of cancer-related mortality worldwide. Despite the proven benefit of screening colonoscopy, its invasive nature, high cost, and low adherence rates limit its use for population-level early detection. Current non-invasive screening tools, such as fecal occult blood testing and stool DNA assays, offer limited sensitivity, particularly for early-stage or right-sided colorectal tumors. Therefore, there is a growing clinical need for a highly sensitive, minimally invasive, and patient-compliant diagnostic approach that can complement existing screening modalities. Circular RNAs (circRNAs) are a novel class of endogenous non-coding RNAs characterized by covalently closed loop structures formed through back-splicing. Unlike linear RNAs, circRNAs are resistant to exonuclease-mediated degradation and are remarkably stable in body fluids. They exhibit tissue- and cancer-specific expression patterns, suggesting strong potential as non-invasive biomarkers. Emerging evidence demonstrates that cell-free circRNAs (cf-circRNAs) circulate in plasma or serum either freely or encapsulated within extracellular vesicles such as exosomes. These cf-circRNAs retain the molecular signatures of their tumor of origin and can be reliably quantified using reverse transcriptase-quantitative PCR (RT-qPCR) or next-generation sequencing (NGS)-based platforms. The CIRCLED study (Circular RNA for Colorectal Cancer Detection) is designed as a multi-center, case-control, observational study aiming to (1) identify diagnostic circRNA candidates from RNA sequencing, and (2) validate a cf-circRNA diagnostic panel capable of differentiating CRC patients from healthy individuals and those with benign colorectal diseases.