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NCT05685524 Clinical Trial

Clinical Study of Pan-cancer DNA Methylation Test in Plasma

Cancer Clinical Trial

Official title:
Development of Diagnostic Model for Multi-cancer Diagnosis Based on DNA Methylation Biomarkers

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05685524
Other study ID # PanCa
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 1, 2022
Est. completion date December 2023

Study information
Verified date January 2023
Source Wuhan Ammunition Life-tech Co., Ltd
Contact Tingting Li, PhD
Phone +8613317163670
Email litt@whammunition.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

We intend to establish an efficient method for plasma cfDNA extraction and Bisulfite transformation to facilitate the detection of DNA methylation status using multiplex fluorescence PCR. Meanwhile, we expect to identify several plasma methylation markers that can be highly sensitive for multi-cancer detection. Finally, we will provide a pan-cancer blood test that is easy to operate, low cost, accurate and easy to promote.

Recruitment information / eligibility
Status Recruiting
Enrollment 3000
Est. completion date December 2023
Est. primary completion date August 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - (1)age >= 18 years. (2) with high suspicion of cancer diagnosed by endoscopy, other imaging examinations, pathological examinations, etc. (3) no treatment with radiotherapy or chemotherapy. Exclusion Criteria: - (1) received antineoplastic treatment such as radiation/chemotherapy. (2) not preserved as required. (3) contaminated or volume is insufficient. (4) unclear pathological results (5) incomplete patient information.

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• DNA methylation test
Cell-free DNA were extracted from plasma collected from individuals of cancer and non-cancerous disease groups, then the DNA was bisulfite converted and tested by DNA methylation assay based on real-time PCR platform.

Locations
Country Name City State
China The first affiliated hospital of Zhengzhou University Zhengzhou Henan

Sponsors (1)
Lead Sponsor Collaborator
Wuhan Ammunition Life-tech Co., Ltd

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Sensitivity The reference standard is the results of histopathological tests immediately after the procedure
Primary Specificity immediately after the procedure
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