Trials / Completed
CompletedNCT03737591
The Implication of Plasma ctDNA Methylation Haplotypes in Detecting Colorectal Cancer and Adenomas
The Implication of Plasma Circulating Tumor DNA Methylation Haplotypes in Detecting Colorectal Cancer and Adenomas: a Multicenter, Cohort Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,138 (actual)
- Sponsor
- Fudan University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
This is a multicenter, clinical study. This study is to evaluate the sensitivity of plasma ctDNA methylation haplotypes in detecting colorectal cancer, adenoma and the specificity in healthy individuals.
Detailed description
Colorectal cancer (CRC) is the third most common cancer worldwide, the second deadliest cancer in the United States. DNA methylation is a commonly used biomarker for non-invasive CRC detection in plasma. The low sensitivity of blood-based tests is due to several limitations of detecting ctDNA in early-stage cancer. We developed and validated a high-throughput methylation-based blood test highly sensitive for colorectal cancer and precancerous lesions. This previously established colorectal tumor-specific plasma ctDNA methylation markers (diagnostic model established by next-generation sequencing of gene loci methylation) had a high sensitivity in CRC patients and a high specificity in healthy individuals in a large retrospective sample study. This prospective, multicenter, clinical study is to further evaluate the sensitivity of plasma ctDNA methylation haplotypes in detecting colorectal cancer, adenoma and the specificity in healthy individuals.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | Next-generation sequencing (NGS) | NGS test for colorectal tumor-specific plasma ctDNA methylation markers prior to endoscopy |
Timeline
- Start date
- 2010-05-01
- Primary completion
- 2018-12-31
- Completion
- 2021-12-31
- First posted
- 2018-11-09
- Last updated
- 2022-01-25
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03737591. Inclusion in this directory is not an endorsement.