NCT02747862

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,500 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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 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.

Conditions

• Attenuated Familial Adenomatous Polyposis
• Deleterious Familial Adenomatous Polyposis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2008-02-01
• Primary completion: 2022-08-17
• Completion: 2022-08-17
• First posted: 2016-04-22
• Last updated: 2022-09-02

Locations

1 site across 1 country: United States