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

welcome to oneFAPvoice

- a positively charged Familial Adenomatous Polyposis community.
  • join today!
recruiting

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

The cookie settings on this website are set to "allow cookies" to give you the best browsing experience possible. If you continue to use this website without changing your cookie settings or you click "Accept" below then you are consenting to this.

Close