Small Bowel Endoscopic Evaluation in Familial Adenomatous Polyposis (FAP)

NCT ID: NCT02656134

Last Updated: 2016-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

55 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-03-31

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Familial Adenomatous Polyposis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Duodenoscopy and enteroscopy

All patients will undergo duodenoscopy and classified according to Spigelman. Patients classified as Spigelman III and IV will undergo enteroscopy.

Intervention Type PROCEDURE

Molecular analysis.

DNA analysis

Intervention Type GENETIC

Other Intervention Names

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Immunohistochemistry

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Pregnancy, lactation
Minimum Eligible Age

15 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Marianny Sulbaran

GI endoscopist, ongoing MSc, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marianny Sulbaran, MD

Role: PRINCIPAL_INVESTIGATOR

PhD

Locations

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University of Sao Paulo Medical School

São Paulo, , Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Marianny Sulbaran, MD

Role: CONTACT

5511 948526841

Facility Contacts

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Adriana Vaz Safatle-Ribeiro, MD, PhD

Role: primary

Role: backup

References

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Campos FG, Sulbaran M, Safatle-Ribeiro AV, Martinez CA. Duodenal adenoma surveillance in patients with familial adenomatous polyposis. World J Gastrointest Endosc. 2015 Aug 10;7(10):950-9. doi: 10.4253/wjge.v7.i10.950.

Reference Type BACKGROUND
PMID: 26265988 (View on PubMed)

Spigelman AD, Talbot IC, Penna C, Nugent KP, Phillips RK, Costello C, DeCosse JJ. Evidence for adenoma-carcinoma sequence in the duodenum of patients with familial adenomatous polyposis. The Leeds Castle Polyposis Group (Upper Gastrointestinal Committee). J Clin Pathol. 1994 Aug;47(8):709-10. doi: 10.1136/jcp.47.8.709.

Reference Type BACKGROUND
PMID: 7962621 (View on PubMed)

Groves CJ, Saunders BP, Spigelman AD, Phillips RK. Duodenal cancer in patients with familial adenomatous polyposis (FAP): results of a 10 year prospective study. Gut. 2002 May;50(5):636-41. doi: 10.1136/gut.50.5.636.

Reference Type BACKGROUND
PMID: 11950808 (View on PubMed)

Mathus-Vliegen EM, Boparai KS, Dekker E, van Geloven N. Progression of duodenal adenomatosis in familial adenomatous polyposis: due to ageing of subjects and advances in technology. Fam Cancer. 2011 Sep;10(3):491-9. doi: 10.1007/s10689-011-9433-2.

Reference Type BACKGROUND
PMID: 21416262 (View on PubMed)

Other Identifiers

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Small bowel profile in FAP

Identifier Type: -

Identifier Source: org_study_id

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