Liquid Biopsy for Early Detection of Colorectal Cancer Using Circular RNA

NCT07224789 | Recruiting

• 1 other identifier: 23228/CIRCLE
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Sensitivity

  Proportion of early-stage (Stage I-II) colorectal cancer patients correctly identified as positive by the circRNA-based diagnostic model.

  Through study completion, an average of 1 year

Secondary Outcomes (2)

• Specificity

  Through study completion, an average of 1 year

• Proportion of correct predictions (true positives and true negatives) among the total cases (i.e., accuracy)

  Through study completion, an average of 1 year

Study Arms (4)

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.

Diagnostic Test: cf-circRNA assay

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.

Diagnostic Test: cf-circRNA assay

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.

Diagnostic Test: cf-circRNA assay

Non-Disease Control - Validation Cohort

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

Diagnostic Test: cf-circRNA assay

Interventions

cf-circRNA assay DIAGNOSTIC_TEST

Circular RNA detection in plasma or serum by RT-qPCR

Colorectal Cancer - Training Cohort; Colorectal Cancer - Validation Cohort; Non-Disease Control - Training Cohort; Non-Disease Control - Validation Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with histologically confirmed colorectal adenocarcinoma (Stages I-III) Patients with benign colorectal diseases (adenoma, polyp) Healthy control individuals with no evidence of malignancy

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• City of Hope Medical Center: lead

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91016, United States

RECRUITING

Related Publications (9)

• Dong Y, He D, Peng Z, Peng W, Shi W, Wang J, Li B, Zhang C, Duan C. Circular RNAs in cancer: an emerging key player. J Hematol Oncol. 2017 Jan 3;10(1):2. doi: 10.1186/s13045-016-0370-2.

  PMID: 28049499 BACKGROUND

• Qu S, Yang X, Li X, Wang J, Gao Y, Shang R, Sun W, Dou K, Li H. Circular RNA: A new star of noncoding RNAs. Cancer Lett. 2015 Sep 1;365(2):141-8. doi: 10.1016/j.canlet.2015.06.003. Epub 2015 Jun 5.

  PMID: 26052092 BACKGROUND

• Jeck WR, Sharpless NE. Detecting and characterizing circular RNAs. Nat Biotechnol. 2014 May;32(5):453-61. doi: 10.1038/nbt.2890.

  PMID: 24811520 BACKGROUND

• Chen LY, Wang L, Ren YX, Pang Z, Liu Y, Sun XD, Tu J, Zhi Z, Qin Y, Sun LN, Li JM. The circular RNA circ-ERBIN promotes growth and metastasis of colorectal cancer by miR-125a-5p and miR-138-5p/4EBP-1 mediated cap-independent HIF-1alpha translation. Mol Cancer. 2020 Nov 23;19(1):164. doi: 10.1186/s12943-020-01272-9.

  PMID: 33225938 BACKGROUND

• Xu H, Liu Y, Cheng P, Wang C, Liu Y, Zhou W, Xu Y, Ji G. CircRNA_0000392 promotes colorectal cancer progression through the miR-193a-5p/PIK3R3/AKT axis. J Exp Clin Cancer Res. 2020 Dec 14;39(1):283. doi: 10.1186/s13046-020-01799-1.

  PMID: 33317596 BACKGROUND

• Long F, Lin Z, Li L, Ma M, Lu Z, Jing L, Li X, Lin C. Comprehensive landscape and future perspectives of circular RNAs in colorectal cancer. Mol Cancer. 2021 Feb 3;20(1):26. doi: 10.1186/s12943-021-01318-6.

  PMID: 33536039 BACKGROUND

• Zhang Y, Luo J, Yang W, Ye WC. CircRNAs in colorectal cancer: potential biomarkers and therapeutic targets. Cell Death Dis. 2023 Jun 9;14(6):353. doi: 10.1038/s41419-023-05881-2.

  PMID: 37296107 BACKGROUND

• Keum N, Giovannucci E. Global burden of colorectal cancer: emerging trends, risk factors and prevention strategies. Nat Rev Gastroenterol Hepatol. 2019 Dec;16(12):713-732. doi: 10.1038/s41575-019-0189-8. Epub 2019 Aug 27.

  PMID: 31455888 BACKGROUND

• Siegel RL, Kratzer TB, Giaquinto AN, Sung H, Jemal A. Cancer statistics, 2025. CA Cancer J Clin. 2025 Jan-Feb;75(1):10-45. doi: 10.3322/caac.21871. Epub 2025 Jan 16.

  PMID: 39817679 BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Ajay Goel, PhD

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Goel Ajay, PhD

CONTACT

626-218-3452; ajgoel@coh.org

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2025
• First Posted: November 5, 2025
• Study Start: January 15, 2025
• Primary Completion (Estimated): June 18, 2026
• Study Completion (Estimated): June 18, 2026
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)