NCT02656134

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
55

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 2, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 14, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 14, 2016

Status Verified

January 1, 2016

Enrollment Period

1.5 years

First QC Date

January 2, 2016

Last Update Submit

January 12, 2016

Conditions

Familial Adenomatous Polyposis

Keywords

Familial Adenomatous Polyposis

Outcome Measures

Primary Outcomes (1)

  • Genetic profile in FAP patients

    one year

Interventions

Duodenoscopy and enteroscopyPROCEDURE

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

Molecular analysis.GENETIC

DNA analysis

Also known as: Immunohistochemistry

Eligibility Criteria

Age15 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Pregnancy, lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Sao Paulo Medical School

São Paulo, Brazil

RECRUITING

Related Publications (4)

  • 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.

    PMID: 26265988BACKGROUND

  • 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.

    PMID: 7962621BACKGROUND

  • 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.

    PMID: 11950808BACKGROUND

  • 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.

    PMID: 21416262BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Small bowel biopsies and blood samples

MeSH Terms

Conditions

Adenomatous Polyposis Coli

Interventions

DuodenoscopyImmunohistochemistry

Condition Hierarchy (Ancestors)

Adenomatous PolypsAdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplastic Syndromes, HereditaryDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesIntestinal PolyposisGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical ProceduresHistocytochemistryCytological TechniquesClinical Laboratory TechniquesHistological TechniquesInvestigative TechniquesImmunologic Techniques

Study Officials

  • Marianny Sulbaran, MD

    PhD

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marianny Sulbaran, MD

CONTACT

5511 948526841mariannysulbaran@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
GI endoscopist, ongoing MSc, PhD

Study Record Dates

First Submitted

January 2, 2016

First Posted

January 14, 2016

Study Start

March 1, 2015

Primary Completion

September 1, 2016

Study Completion

December 1, 2016

Last Updated

January 14, 2016

Record last verified: 2016-01

Locations

BR(1)