Preliminary Evaluation of Septin9 in Patients With Hereditary Colon Cancer Syndromes

Completed

• Conditions: Familial Adenomatous Polyposis; Colorectal Cancer; Lynch Syndrome; Hnpcc; Map Syndrome

• Registration Number: NCT02198092
• Lead Sponsor: University of Pennsylvania

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-15
• Study First Submitted QC: 2014-07-22
• Study First Posted: 2014-07-23
• Status Verified: 2019-08
• Primary Completion: 2019-08
• Study Completion: 2019-08
• Last Update Submitted: 2019-08-27
• Last Update Posted: 2019-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Septin9 Plasma Levels	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 Outcome Measures

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

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States