Exploratory Study of a Novel Based rbcDNA Liquid Biopsy Technique for Colorectal Cancer Early Detection

Exploration of a novel rbcDNA liquid biopsy technique for early detection of colorectal cancer is a promising development in the field of disease diagnosis and screening. This technique has the potential to establish an efficient and sensitive system for the early detection of colorectal cancer, which can provide a new perspective for individual health monitoring.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer; Adenoma; Adenomatous Polyps; Advanced Adenoma
• Intervention / Treatment: Diagnostic test: rbcDNA test

Detailed Description

Patients who are at high risk of developing colorectal cancer and willing to undergo colonoscopy examination will be asked to collect a stool sample prior to bowel preparation for commercially available FIT (fecal immunochemical test) assay, as well as a blood sample for rbcDNA testing. The colonoscopy and histopathologic examination will be used as a reference for the results obtained from these tests.

• Study Type: Observational
• Enrollment (Actual): 598

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Second Affiliated Hospital, School of Medicine, Zhejiang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Subjects advanced adenomas and patients with confirmed CRC

Description

Inclusion Criteria:

1. Age:40-74Years
2. Sex:All
3. Willing to provide written consent
4. Plan to undergo colorectaloscopy or surgical treatment and be able to provide a complete medical history and cooperate with blood sampling and follow-up visits，other operation.

For advanced adenomas (AA) group:

1. Adenomatous polyps with ≥25% villous component, high-grade dysplasia (HGD), or a diameter ≥10 mm were considered AA. Sessile serrated lesions with diameters ≥10 mm.
2. treatment-naive
3. No other comorbid tumors

For CRC group:

1. Confirmed CRC patients
2. treatment-naive
3. No other comorbid tumors

Exclusion Criteria:

1. Patients with colorectal cancer who have received prior treatment.
2. FAP (familial adenomatous polyposis), Crohn's disease, ulcerative colitis
3. Participants taking anticoagulants such as aspirin or warfarin, or those with coagulation disorders.
4. Prior history of colonoscopy within the past 5 years and removal of lesions
5. Pregnancy or intestinal infarction people
6. Unable to provide informed consent
7. Participants in other clinical trials or who have participated in other clinical trials within 60 days.
8. Unable to provide stool sample and follow-up visits.
9. Presence of major infectious diseases (e.g. HIV, etc.)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CRC group; Retrospective enrollment of subjects with confirmed colorectal cancer	Diagnostic test: rbcDNA test; fecal immunochemical test; Other Names: FIT
advanced adenomas (AA) group; Prospective enrollment of subjects with advanced adenomas	Diagnostic test: rbcDNA test; fecal immunochemical test; Other Names: FIT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluating the sensitivity, specificity, and accuracy of rbcDNA in colorectal cancer screening	A diagnostic colonoscopy procedure is the reference method. Lesions will be confirmed as malignant by histopathologic examination. The rbcDNA test was deployed to a composite score. The tests were processed independently of colonoscopy procedure.	Through study completion，an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity of the rbcDNA screening test with comparison to FIT, with respect to advanced adenoma (AA) and CRC	A diagnostic colonoscopy procedure is the reference method. Lesions will be confirmed as malignant by histopathologic examination. The rbcDNA and FIT test were performed.	Through study completion，an average of 1 year

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Collaborators: Timing Biotech Co.Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2023
• Primary Completion (Actual): December 28, 2023
• Study Completion (Actual): January 10, 2024

Study Registration Dates

• First Submitted: May 4, 2023
• First Submitted That Met QC Criteria: May 23, 2023
• First Posted (Actual): May 25, 2023

Study Record Updates

• Last Update Posted (Actual): August 27, 2024
• Last Update Submitted That Met QC Criteria: August 26, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Adenoma; Adenomatous Polyps
• Other Study ID Numbers: SAHZhejiangU Timing

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No