Preliminary Evaluation of Septin9 in Patients With Hereditary Colon Cancer Syndromes | oneFAPvoice

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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: recruiting

purpose:

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 2020

last updated: February 15, 2019

size / enrollment: 46

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:
• Informed consent provided
• Age > or = to 18 years of age
• Patient group FAP
- Clinical diagnosis of familial adenomatous polyposis
• Patient group Lynch syndrome Clinical diagnosis of Lynch syndrome
• Patient group MAP
- Clinical diagnosis of MYH-associated polyposis and presence of more than 20 colon polyps
• Control group (FAP)
- Genetically related family member of patient
• Patients: Able and willing to attend routine follow-up as advised
• Controls, i.e. relatives of patients: Willingness to give blood at each routine follow-up as advised for the diseased relative

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

contacts:
Julie Starr, (215) 349-8527, Jstarr@mail.med.upenn.edu
Carly Price, (215) 349-8556, Carly.price@uphs.upenn.edu

investigators: Anil K. Rustgi, MD

investigators: Anil K. Rustgi, MD

locations: United States

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