Trials / Completed
CompletedNCT05508503
A Study on a Blood-based Dual-target Test for CRC Detection
Validation of a ctDNA Methylation-based Dual-target Test for the Detection of Colorectal Cancer: a Multicenter Clinical Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,378 (actual)
- Sponsor
- Changhai Hospital · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Accepted
Summary
To evaluate the effectiveness and accuracy of the ctDNA dual-target test kit in a large case-control cohort for the detection of colorectal cancer and advanced adenomas.
Detailed description
Usually, colorectal cancers (CRCs) diagnosed in their early stages are curable, especially precancerous lesions (adenomas, polyps) that can be removed during a colonoscopy.However, due to low patient compliance and limited resources, colonoscopy is not feasible for screening the average-risk population. gFOBT/FIT are limited by their low sensitivity and high false-positive rate. Compared to colonoscopy and stool DNA tests, blood-based methylation tests showed greater patient compliance and convenience. Hypermethylated NTMT1 and MAP3K14-AS1 were found in multiple cohorts of CRC samples in our previous study. In this study, we aimed to evaluate the effectiveness and accuracy of the ctDNA dual-target(NTMT1 and MAP3K14-AS1) test kit in 5 tertiary hospitals around china for the detection of colorectal cancer and advanced adenomas. Fecal immunochemical test (FIT) will also privided to participants in the study. Sanger sequencing would be performed to evalute the accuracy of the dual-target methylation detection test kit.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | Test of methylated NTMT1 and MAP3K14-AS1 | A dual-target test kit to detect methylated NTMT1 and MAP3K14-AS1 in blood samples. |
| DIAGNOSTIC_TEST | FIT | Fecal immunochemical test（optional） |
Timeline
- Start date
- 2022-10-21
- Primary completion
- 2023-08-11
- Completion
- 2023-08-11
- First posted
- 2022-08-19
- Last updated
- 2024-02-16
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05508503. Inclusion in this directory is not an endorsement.