Non-Surgical Management of Attenuated and Deleterious (Classical) Familial Adenomatous Polyposis: A Long-term Surveillance Program
NCT ID: NCT02747862
Last Updated: 2022-09-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1500 participants
OBSERVATIONAL
2008-02-29
2022-08-17
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Attenuated Familial Adenomatous Polyposis
Chart review study to evaluate the outcomes of subjects with Attenuated Familial Adenomatous Polyposis (AFAP) who have not undergone surgical resection of the colon.
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.
Deleterious Familial Adenomatous Polyposis
Chart review study to evaluate the outcomes of subjects with Deleterious Familial Adenomatous Polyposis (FAP) who have not undergone surgical resection of the colon.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
Yes
Sponsors
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M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Patrick Lynch, MD, JD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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University of Texas MD Anderson Cancer Center Website
Other Identifiers
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DR08-0006
Identifier Type: -
Identifier Source: org_study_id
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