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Small Bowel Endoscopic Evaluation in Familial Adenomatous Polyposis (FAP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02656134
Recruitment Status : Unknown
Verified January 2016 by Marianny Sulbaran, University of Sao Paulo.
Recruitment status was:  Recruiting
First Posted : January 14, 2016
Last Update Posted : January 14, 2016
Information provided by (Responsible Party):
Marianny Sulbaran, University of Sao Paulo

Brief Summary:
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.

Condition or disease Intervention/treatment
Familial Adenomatous Polyposis Procedure: Duodenoscopy and enteroscopy Genetic: Molecular analysis.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 55 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Small Bowel Endoscopic Evaluation in Familial Adenomatous Polyposis: A Prospective Clinical, Immunopathologic and Molecular Analysis
Study Start Date : March 2015
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : December 2016

Intervention Details:
  • Procedure: Duodenoscopy and enteroscopy
    All patients will undergo duodenoscopy and classified according to Spigelman. Patients classified as Spigelman III and IV will undergo enteroscopy.
  • Genetic: Molecular analysis.
    DNA analysis
    Other Name: Immunohistochemistry

Primary Outcome Measures :
  1. Genetic profile in FAP patients [ Time Frame: one year ]

Biospecimen Retention:   Samples With DNA
Small bowel biopsies and blood samples

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Familial Adenomatous Polyposis with colectomy, or scheduled for surgery.

Inclusion Criteria:

  • Patients with Familial Adenomatous Polyposis with colectomy, or scheduled for surgery.

Exclusion Criteria:

  • Pregnancy, lactation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02656134

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Contact: Marianny Sulbaran, MD 5511 948526841

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University of Sao Paulo Medical School Recruiting
Sao Paulo, Brazil
Contact: Adriana Vaz Safatle-Ribeiro, MD, PhD         
Sponsors and Collaborators
University of Sao Paulo
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Principal Investigator: Marianny Sulbaran, MD PhD
Additional Information:

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Responsible Party: Marianny Sulbaran, GI endoscopist, ongoing MSc, PhD, University of Sao Paulo Identifier: NCT02656134    
Other Study ID Numbers: Small bowel profile in FAP
First Posted: January 14, 2016    Key Record Dates
Last Update Posted: January 14, 2016
Last Verified: January 2016
Keywords provided by Marianny Sulbaran, University of Sao Paulo:
Familial Adenomatous Polyposis
Additional relevant MeSH terms:
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Colorectal Neoplasms
Nasopharyngeal Neoplasms
Adenomatous Polyposis Coli
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Adenomatous Polyps
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplastic Syndromes, Hereditary
Intestinal Polyposis
Genetic Diseases, Inborn