Clinical Trial: Non-Surgical Management of Attenuated and Deleterious (Classical) Familial Adenomatous Polyposis: A Long-term Surveillance Program

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Non-Surgical Management of Attenuated and Deleterious (Classical) Familial Adenomatous Polyposis: A Long-term Surveillance Program

Brief 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.


Detailed Summary:

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.


Sponsor: M.D. Anderson Cancer Center

Current Primary Outcome: Chart Review of Outcomes of Participants with Attenuated Familial Adenomatous Polyposis (AFAP) and Deleterious Familial Adenomatous Polyposis (FAP) Undergoing Endoscopic Surveillance [ Time Frame: 12 years ]

For comparisons between groups, the Mann-Whitney test used.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: M.D. Anderson Cancer Center

Dates:
Date Received: April 14, 2016
Date Started: February 2008
Date Completion:
Last Updated: October 26, 2016
Last Verified: October 2016