Spots Global Cancer Trial Database for Clinical Validation of ColonAiQ (a Blood-based Assay Targeting ctDNA Methylation) for Colorectal Cancer Detection
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Trial Identification
Brief Title: Clinical Validation of ColonAiQ (a Blood-based Assay Targeting ctDNA Methylation) for Colorectal Cancer Detection
Official Title: Clinical Validation of ColonAiQ (a Blood-based Assay Targeting Circulating Tumor DNA Methylation) for Colorectal Cancer Detection
Study ID: NCT06347887
Conditions
Interventions
Study Description
Brief Summary: The DNA methylation targets in preoperative plasma samples of the subjects will be detected by the multi-gene methylation test (ColonAiQ), and the test accuracy will be evaluated by compared with the clinical diagnosis evidence.
Detailed Description: The accuracy of ColonAiQ test in clinical testing will be evaluated in the multicenter, prospective study. Patients with colorectal cancer, intestinal polyps, adenomas and other non-neoplastic diseases of the digestive system, and patients with non-colorectal cancer such as gastric cancer, esophageal cancer, breast cancer and lung cancer will be enrolled. In this study, all cfDNA will be tested by fluorescence quantitative PCR, and some samples will be tested by NGS to verify the effectiveness of ColonAiQ test. Clinical diagnosis reports and methylation test results will be blinded to the lab tester and clinician respectively.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: Yes
Locations
The Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu, China
Cancer Hospital Affiliated to Shandong First Medical University (Shandong Institute of Cancer Prevention and Control, Shangdong Cancer Hospital), Jinan, Shandong, China
Shanxi Provincial People's Hospital, Taiyuan, Shanxi, China
Xi'an Daxing Hospital, Xi'an, Shanxi, China
Xi'an Gaoxin Hospital, Xi'an, Shanxi, China
Zhejiang provincial people's hospital, Hangzhou, Zhejiang, China
Fudan University Shanghai Cancer Center, Shanghai, , China
Contact Details
Name: Guoxiang Cai, M.D. Ph.D.
Affiliation: Fudan University
Role: PRINCIPAL_INVESTIGATOR
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