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Small Bowel Endoscopic Evaluation in Familial Adenomatous Polyposis (FAP)
study id #: NCT02656134
condition: Familial Adenomatous Polyposis
status: Recruiting
purpose:Background and study aim The relative risks of duodenal adenocarcinoma and ampullary carcinoma in Familial Adenomatous Polyposis (FAP) have been estimated 100 to 330 times higher than in general population. However risk factors, including a genotype-phenotype association for duodenal cancer in FAP has not been fully understood. The aim of this study is to determine risk factors associated with the development of advanced duodenal polyposis and ampullary adenomas in colectomized patients with FAP.
intervention:
Procedure: Duodenoscopy and enteroscopy
Genetic: Molecular analysis
start date: March 2015
estimated completion: September 2016
last updated: January 12, 2016
size / enrollment: 55
study design:
Observational Model: Cohort
Time Perspective: Prospective
primary outcomes:
- Genetic profile in FAP patients [ Time Frame: one year ] [ Designated as safety issue: No ]
inclusion criteria: Patients with Familial Adenomatous Polyposis with colectomy, or scheduled for surgery.
exclusion criteria: Pregnancy, lactation
sponsor: University of Sao Paulo
contacts: Adriana Vaz Safatle-Ribeiro, MD, PhD
5511 948526841
adrisafatleribeiro@terra.com.br
investigators: Marianny Sulbaran, MD PhD
locations: Brazil