Small Bowel Endoscopic Evaluation in Familial Adenomatous Polyposis (FAP)

study id #: NCT02656134

condition: Familial Adenomatous Polyposis

status: status unknown

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 14, 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:

exclusion criteria: Pregnancy, lactation

sponsor: University of Sao Paulo

investigators: Marianny Sulbaran, MD PhD

trial center locations: Brazil