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

NCT05875584 | Completed

• 1 other identifier: SAHZhejiangU Timing
• Study Type: observational
• Target: 598
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer; Adenomatous Polyps; Adenoma; Advanced Adenoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

advanced adenomas (AA) group

Prospective enrollment of subjects with advanced adenomas

Diagnostic Test: rbcDNA test

CRC group

Retrospective enrollment of subjects with confirmed colorectal cancer

Diagnostic Test: rbcDNA test

Interventions

rbcDNA test DIAGNOSTIC_TEST

fecal immunochemical test

Also known as: FIT

CRC group; advanced adenomas (AA) group

Eligibility Criteria

• Age: 40 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects advanced adenomas and patients with confirmed CRC

You may qualify if:

• Age:40-74Years
• Sex:All
• Willing to provide written consent
• 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:
• 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.
• treatment-naive
• No other comorbid tumors
• For CRC group:
• Confirmed CRC patients
• treatment-naive
• No other comorbid tumors

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Adenomatous Polyps; Adenoma

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; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief

Study Record Dates

• First Submitted: May 4, 2023
• First Posted: May 25, 2023
• Study Start: May 18, 2023
• Primary Completion: December 28, 2023
• Study Completion: January 10, 2024
• Last Updated: August 27, 2024

Record last verified: 2024-08

Locations

CN (1)