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.