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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
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 2017
last updated: September 6, 2016
phase of development: Not Available
size / enrollment: 46
study design: Observational Model: Case Control, Time Perspective: Prospective
- Septin9 Plasma Levels [ Time Frame:Up to 2 years ] [ Designated as safety issue: No ]
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.
- Septin9 Plasma Levels Versus Polyps [ Time Frame:Up to 2 years ] [ Designated as safety issue:No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Correlation of circulating colonic epithelial cell number with Septin9 levels
- 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
- Known infection with Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV)
- Current diagnosis of colorectal cancer
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