NCT02198092

Preliminary Evaluation of Septin9 in Patients With Hereditary Colon Cancer Syndromes

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 24 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Familial Adenomatous Polyposis
• Map Syndrome
• Lynch Syndrome
• Hnpcc
• Colorectal Cancer

Interventions

Type	Name	Description
OTHER	Epi proColon Testing	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.

Timeline

• Start date: 2014-07-01
• Primary completion: 2019-08-01
• Completion: 2019-08-01
• First posted: 2014-07-23
• Last updated: 2019-08-28

Locations

1 site across 1 country: United States