Trials / Completed
CompletedNCT04287335
Multitarget Stool FIT-DNA Study for Colorectal Cancer Early Screening in China
Stool KRAS Mutation, BMP3/NDRG4 Methylation and FIT Panel Test for the Detection of Colorectal Advanced Neoplasia in High Risk Chinese Patients
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 4,758 (actual)
- Sponsor
- Zhejiang University · Academic / Other
- Sex
- All
- Age
- 40 Years – 74 Years
- Healthy volunteers
- Accepted
Summary
The primary objective is to determine the diagnostic sensitivity and specificity of the newly developed multitarget FIT-DNA Colorectal Cancer (CRC) screening test (ColoClear) for detecting advanced neoplasia (including colorectal cancer and advanced adenomas) in high risk patients, using colonoscopy as the reference method. The secondary objective is to compare the screening performance of the multitarget FIT-DNA test with commercially available FIT (Fecal Immunochemical Test) assay in detecting advanced neoplasia.
Detailed description
The study will be carried out in 8 tier-3A hospitals throughout China. Patients who are at high risk of developing colorectal cancer and willing to conduct colonoscopy examination will be asked to collect stool sample prior to bowl preparation for multitarget FIT-DNA test and commercially available FIT assay. Colonoscopy and histopathologic examination are used as reference.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | Multitarget stool FIT-DNA test - ColoClear | Multitarget stool FIT-DNA test |
| DIAGNOSTIC_TEST | FIT | fecal immunochemical test |
| PROCEDURE | Colonoscopy | diagnostic colonoscopy |
Timeline
- Start date
- 2018-09-18
- Primary completion
- 2019-12-08
- Completion
- 2020-09-13
- First posted
- 2020-02-27
- Last updated
- 2020-12-08
Locations
8 sites across 1 country: China
Source: ClinicalTrials.gov record NCT04287335. Inclusion in this directory is not an endorsement.