This is an observational, case-control study evaluating the quantitative level of Septin9 in plasma pre- and post-colectomy in hereditary colorectal cancer (CRC) syndrome patients (Familial Adenomatous Polyposis (FAP), Lynch syndrome (also known as HNPCC), and Multiple Adenomatous Polyposis (MAP, also known as MYK/MYH) cases) and genetically related FAP-family members as controls and references.
Study Type
OBSERVATIONAL
Enrollment
24
Plasma specimens will be collected and processed according to the Instructions for Use of the Epi proColon investigational device. For circulating colonic epithelial cell analysis, at least one ml whole blood will be required for analysis. Samples will be analyzed for circulating epithelial cells using the geometrically enhanced immunocapture device (GEDI; Gleghorn et al., 2009). Circulating epithelial cells will be captured using EpCAM antibodies and quantified by immunofluorescence microscopy as defined as cells that are DAPI+, CK+, CD45-. Captured cells will be fixed and stored at -20˚C.
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Septin9 Plasma Levels
The primary objective of the study is the observational analysis of quantitative Septin9 plasma levels over time in hereditary CRC syndrome patients pre- and post-colectomy.
Time frame: Up to 2 years
Septin9 Plasma Levels Versus Polyps
• Correlation of quantitative Septin9 plasma levels with the approx. number of polyps
Time frame: Up to 2 years
Pre- and Post-Colectomy Colonic Epithelial Cell Numbers
• Correlation of circulating colonic epithelial cell number pre- and post-colectomy
Time frame: Up to 2 years
Septin9 Levels Versus Circulating Colonic Epithelial Cell Numbers
• Correlation of circulating colonic epithelial cell number with Septin9 levels
Time frame: Up to 2 years
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