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

NCT02747862 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1500

Last updated 2022-09-02

No results posted yet for this study

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.

Conditions

  • Attenuated Familial Adenomatous Polyposis
  • Deleterious Familial Adenomatous Polyposis

Interventions

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.

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Patrick Lynch, MD, JD · M.D. Anderson Cancer Center

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2022-08-17
Completion
2022-08-17

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02747862 on ClinicalTrials.gov