Trials / Unknown
UnknownNCT03411707
Multiple Screening Methods for the Detection of Chinese Colorectal Advanced Adenomatous Polyps and Cancer
A Multicenter Clinical Trial for the Comparison Among Fecal Immunochemical Test, Stool DNA Test and Blood mRNA Test in Chinese Colorectal Cancer Screening
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,200 (estimated)
- Sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University · Academic / Other
- Sex
- All
- Age
- 45 Years – 80 Years
- Healthy volunteers
- Accepted
Summary
The primary objective is to determine the sensitivity and specificity of two Colorectal Cancer (CRC) screening methods, including stool DNA test and blood mRNA test, for colorectal cancer in Chinese population, with colonoscopy as reference method. Lesions will be confirmed as malignant or precancerous by colonoscopy and histopathologic examination. The secondary objective is to compare the performance of these two CRC screening methods to a commercially available FIT assay, both with respect to cancer and advanced adenoma. Lesions will be confirmed as malignant or precancerous by colonoscopy and histopathologic examination.
Detailed description
Participants who are at high risk of developing colorectal cancer will be asked to collect two stool samples one for the stool DNA test and the other for the commercially available FIT assay, and a single blood sample for the blood mRNA test. Subjects will undergo colonoscopy within 6 months of enrollment. Representative histopathology slides from tissue biopsied or excised during colonoscopy and those from subsequent definitive surgery may be retrieved in order to be evaluated by pathologists to confirm the diagnosis and staging.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | Stool DNA test | Stool DNA test could detect specific gene methylation in stool DNA. Blood mRNA test could detect specific set of gene expression in blood. |
Timeline
- Start date
- 2018-03-19
- Primary completion
- 2023-06-01
- Completion
- 2023-06-01
- First posted
- 2018-01-26
- Last updated
- 2022-05-06
Locations
3 sites across 1 country: China
Source: ClinicalTrials.gov record NCT03411707. Inclusion in this directory is not an endorsement.