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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02747862
Other study ID # DR08-0006
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 2008
Est. completion date August 17, 2022

Study information

Verified date August 2022
Source M.D. Anderson Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The primary objective of this chart review study is to evaluate the outcomes of subjects with Attenuated Familial Adenomatous Polyposis (AFAP) and Deleterious Familial Adenomatous Polyposis (FAP) who have not undergone surgical resection of the colon. A secondary objective of this study is to compare 1) the colonoscopic and pathology histories including history of ampullary adenoma in the duodenum over family generations, 2) the use of chemopreventive medications, and 3) clinical features of subjects who pursued prophylactic surgical resection of the colon with those that have elected to continue routine colonoscopic surveillance in an effort to better characterize factors (e.g. polyp burden, ampullary adenoma and level of dysplasia, etc) which may influence management decisions.


Description:

The UTMDACC family history database will be queried for the presence of cases meeting the above criteria (attenuated Familial Adenomatous Polyposis (FAP), classical AFP [i.e. identifiable APC mutation], and/or a compatible family history or personal adenoma burden of > 50 adenomas). The data related to the patients with attenuated FAP and classical AFP who underwent endoscopic surveillance or surgery will be collected through chart review and all data is retrospective as of February 15, 2016. The University of Texas MD Anderson Cancer Center (UTMDACC) medical record number for these cases will be used to identify the patient in ClinicStation: 1) records of endoscopy procedures, 2) operative reports, and 3) associated clinic notes will be reviewed for: a) whether the above evaluation criteria have been met, b) age, c) gender, d) age at initial colonoscopy, e) total number of colonoscopies, f) number of adenomas identified, g) cancer diagnoses, h) chemopreventive medications, i) type of surgery, j) number of hospitalizations, k) length of hospital stay, l) identification of an underlying APC mutation, and ll) family history information. The UT MDACC family history database will also be reviewed for updated family history information including ampullary adenomas and outcomes of genetic testing for identified cases.


Recruitment information / eligibility

Status Completed
Enrollment 1500
Est. completion date August 17, 2022
Est. primary completion date August 17, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: 1. Participants with either a genetic diagnosis of AFAP/FAP (i.e. an identifiable APC gene mutation), and/or a compatible family history and pathology including history of ampullary adenoma in the duodenum over family generations, or personal adenoma burden of > 50 adenomas are to be included. Exclusion Criteria: 1. Participants who do not have with Attenuated Familial Adenomatous Polyposis (AFAP) and Deleterious Familial Adenomatous Polyposis (FAP).

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Chart Review
Database queried for the presence of cases meeting criteria (attenuated FAP, classical AFP [i.e. identifiable APC mutation], and/or a compatible family history or personal adenoma burden of > 50 adenomas). The data related to the patients with attenuated FAP and classical AFP who underwent endoscopic surveillance or surgery collected through chart review and all data is retrospective as of February 15, 2016.

Locations

Country Name City State
United States University of Texas MD Anderson Cancer Center Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Chart Review of Outcomes of Participants with Attenuated Familial Adenomatous Polyposis (AFAP) and Deleterious Familial Adenomatous Polyposis (FAP) Undergoing Endoscopic Surveillance For comparisons between groups, the Mann-Whitney test used. 12 years
See also
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Recruiting NCT05223036 - Testing Obeticholic Acid for Familial Adenomatous Polyposis Phase 2