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

Completed

• Conditions: Adenoma; Colorectal Cancer; Adenomatous Polyps; Advanced Adenoma
• Interventions: Diagnostic Test: rbcDNA test

• Registration Number: NCT05875584
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary

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.

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 Timeline

• Study First Submitted: 2023-05-04
• Study Start: 2023-05-18
• Study First Submitted QC: 2023-05-23
• Study First Posted: 2023-05-25
• Primary Completion: 2023-12-28
• Study Completion: 2024-01-10
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-26
• Last Update Posted: 2024-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 598

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CRC group	rbcDNA test	Retrospective enrollment of subjects with confirmed colorectal cancer
advanced adenomas (AA) group	rbcDNA test	Prospective enrollment of subjects with advanced adenomas

Primary Outcome Measures

Name	Time	Method
Evaluating the sensitivity, specificity, and accuracy of rbcDNA in colorectal cancer screening	Through study completion，an average of 1 year	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Second Affiliated Hospital, School of Medicine, Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China