Specimen Collection Protocol for the Performance Evaluation of the Septin 9 Assay
50 Years
N/A
Both
Colorectal Cancer
Trial Information
Specimen Collection Protocol for the Performance Evaluation of the Septin 9 Assay
Inclusion Criteria:
- 50 years of age or older at the time of the blood draw
- Histologically confirmed or strong clinical suspicion of adenocarcinoma of the colon
or rectum
- CRC defined as invasive adenocarcinoma
Exclusion Criteria:
- Previous personal history of colorectal cancer
- Any cancer specific treatment (e.g. polypectomy, chemotherapy, radiation, or surgery)
prior to blood draw, including neoadjuvant treatment
- Known infection with HIV, HBV or HCV
- Subject concurrently receiving intravenous fluid at the time of the specimen
collection
Type of Study:
Interventional
Study Design:
Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic
Outcome Measure:
Effectiveness of the Epi proColon test
Outcome Description:
The primary objective of the investigation is to determine the safety and effectiveness of the Epi proColon test in precision and reproducibility studies and varying conditions including interfering substances and co-morbidities associated with the testing population. The specimens collected as described in this protocol will be used in the experiments needed to achieve this objective. Validate the Stability of the Septin 9 Biomarker.
Outcome Time Frame:
12 months
Safety Issue:
No
Authority:
United States: Institutional Review Board
Study ID:
Epigenomics_SPR0012
NCT ID:
NCT01329718
Start Date:
May 2011
Completion Date:
December 2012
Related Keywords:
- Colorectal Cancer
- Stability of the Septin 9 biomarker
- Epi Pro Colon Test
- CRC
- Colorectal Neoplasms
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