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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05875584
• Other study ID #: SAHZhejiangU Timing
• Status: Completed
• Start date: May 18, 2023
• Est. completion date: January 10, 2024

Study information

• Verified date: January 2024
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 598
• Est. completion date: January 10, 2024
• Est. primary completion date: December 28, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 74 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Adenoma
• Adenomatous Polyps
• Advanced Adenoma
• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Diagnostic Test:
• rbcDNA test
fecal immunochemical test

Locations

Country	Name	City	State
China	Second Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang

Sponsors (2)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University	Timing Biotech Co.Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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