Trials / Completed
CompletedNCT04027790
Plasma-based Colorectal Cancer Screening Research & Development
Clinical Sample Protocol for Plasma-based Colorectal Cancer Screening Research & Development
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 354 (actual)
- Sponsor
- Epigenomics, Inc · Industry
- Sex
- All
- Age
- 45 Years – 84 Years
- Healthy volunteers
- Accepted
Summary
The objective of this Clinical Sample Collection Study is to develop a biobank of appropriately collected plasma samples from colorectal cancer patients (i.e. AJCC/UICC stages 0, I, II, III) prior to therapeutic intervention, and from people reporting for colorectal cancer screening by colonoscopy, prior to bowel preparation.
Detailed description
The objective of this Clinical Sample Collection Study is to develop a biobank of appropriately collected plasma samples from colorectal cancer patients (i.e. AJCC/UICC stages 0, I, II, III) prior to therapeutic intervention, and from people reporting for colorectal cancer screening by colonoscopy, prior to bowel preparation. Samples in the colorectal cancer biobank will be used to: 1) assess the clinical performance of novel biomarkers for colorectal cancer screening; 2) develop improved processing workflows for the Epi proColon® test; 3) develop an automated Epi BiSKit workflow.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | Epi proColon | Analysis of DNA methylation status for Septin9 and additional biomarkers |
Timeline
- Start date
- 2019-05-03
- Primary completion
- 2020-03-31
- Completion
- 2020-03-31
- First posted
- 2019-07-22
- Last updated
- 2021-02-02
Locations
5 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04027790. Inclusion in this directory is not an endorsement.