Preliminary Evaluation of Septin9 in Patients With Hereditary Colon Cancer Syndromes

study id #: NCT02198092

condition: Familial Adenomatous Polyposis, Map Syndrome, Lynch Syndrome, HNPCC, Colorectal Cancer

status: completed

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.

intervention: Other: Epi proColon Testing

start date: July 2014

estimated completion: August 2019

last updated: August 28, 2019

size / enrollment: 24

study design: Observational Model: Case Control, Time Perspective: Prospective

primary outcomes:

• Septin9 Plasma Levels [ Time Frame: Up to 2 years ]
  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.

secondary outcomes:

• Septin9 Plasma Levels Versus Polyps [ Time Frame: Up to 2 years ]
  Correlation of quantitative Septin9 plasma levels with the approx. number of polyps
  
• Pre- and Post-Colectomy Colonic Epithelial Cell Numbers [ Time Frame: Up to 2 years ]
  Correlation of circulating colonic epithelial cell number pre- and post-colectomy
  
• Septin9 Levels Versus Circulating Colonic Epithelial Cell Numbers [ Time Frame: Up to 2 years ]
  Correlation of circulating colonic epithelial cell number with Septin9 levels

inclusion criteria:

exclusion criteria:
• Known infection with Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV)
• Current diagnosis of colorectal cancer
• Pregnancy

sponsor: University of Pennsylvania

investigators: Bryson Katona, MD

trial center locations: United States