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Clinical Validation of ColonAiQ (a Blood-based Assay Targeting ctDNA Methylation) for Colorectal Cancer Detection - Trial NCT06347887

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.

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NCT06347887
Completed
diagnostic test
Trial Details
ClinicalTrials.gov โ€ข NCT06347887
View on ClinicalTrials.gov
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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

Study Focus

Colorectal Cancer

ColonAiQ test and Colonoscopy

Observational

diagnostic test

Sponsor & Location

Singlera Genomics Inc.

Xuzhou,Jinan,Taiyuan,Xi'an,Xi'an,Hangzhou,Shanghai, China

Timeline & Enrollment

N/A

May 31, 2021

Jan 16, 2024

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 colon
Malignant neoplasm: Descending colon
Malignant neoplasm: Colon, unspecified
Malignant neoplasm: Ascending colon
Malignant neoplasm: Overlapping lesion of colon

Data Source

ClinicalTrials.gov

NCT06347887

Non-Device Trial