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NCT06347887Completed

Clinical Validation of ColonAiQ (a Blood-based Assay Targeting ctDNA Methylation) for Colorectal Cancer Detection

Clinical Validation of ColonAiQ (a Blood-based Assay Targeting Circulating Tumor DNA Methylation) for Colorectal Cancer Detection
Singlera Genomics Inc.ClinicalTrials.govdiagnostic test
Verified
Study focus
Disease/Condition
Colorectal Cancer
Drug/Device/Intervention
ColonAiQ test and Colonoscopy
Study type
Observational
Intervention type
diagnostic test
Sponsor & location
Primary sponsor
Singlera Genomics Inc.
Location
Xuzhou,Jinan,Taiyuan,Xi'an,Xi'an,Hangzhou,Shanghai, China
Timeline & enrollment
Phase
N/A
Start date
May 31, 2021
End date
Jan 16, 2024
Enrollment
1965 participants
Primary outcome

Sensitivity for colorectal cancer with ColonAiQ test,Specificity for colorectal cancer with ColonAiQ test

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.

ICD-10 classifications
Malignant neoplasm of colonMalignant neoplasm: Descending colonMalignant neoplasm: Colon, unspecifiedMalignant neoplasm: Ascending colonMalignant neoplasm: Overlapping lesion of colon
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06347887
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06347887 through Pure Global AI's free database. This phase not specified trial is sponsored by Singlera Genomics Inc. and is currently Completed. The study focuses on Colorectal Cancer. Target enrollment is 1965 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.