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

NCT02747862 | Completed

• 1 other identifier: DR08-0006
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Attenuated Familial Adenomatous Polyposis; Deleterious Familial Adenomatous Polyposis

Keywords

Attenuated Familial Adenomatous Polyposis; AFAP; Deleterious Familial Adenomatous Polyposis; FAP; Chart review

Outcome Measures

Primary Outcomes (1)

• Chart Review of Outcomes of Participants with Attenuated Familial Adenomatous Polyposis (AFAP) and Deleterious Familial Adenomatous Polyposis (FAP) Undergoing Endoscopic Surveillance

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

  12 years

Study Arms (2)

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.

Other: Chart Review

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.

Other: Chart Review

Interventions

Chart Review OTHER

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.

Attenuated Familial Adenomatous Polyposis; Deleterious Familial Adenomatous Polyposis

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants with either a genetic diagnosis of AFAP/FAP (i.e. an identifiable APC gene mutation), and/or a compatible family history and pathology including history of ampullary adenoma in the duodenum over family generations, or personal adenoma burden of \> 50 adenomas at MD Anderson Cancer Center in Houston, Texas.

You may qualify if:

• \. Participants with either a genetic diagnosis of AFAP/FAP (i.e. an identifiable APC gene mutation), and/or a compatible family history and pathology including history of ampullary adenoma in the duodenum over family generations, or personal adenoma burden of \> 50 adenomas are to be included.

You may not qualify if:

• \. Participants who do not have with Attenuated Familial Adenomatous Polyposis (AFAP) and Deleterious Familial Adenomatous Polyposis (FAP).

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Attenuated familial adenomatous polyposis

Study Officials

• Patrick Lynch, MD, JD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2016
• First Posted: April 22, 2016
• Study Start: February 1, 2008
• Primary Completion: August 17, 2022
• Study Completion: August 17, 2022
• Last Updated: September 2, 2022

Record last verified: 2022-08

Locations

US (1)