Review of Post-Study Clinical Endoscopy Reports in Follow Up to MAY2016-07-01

Completed

• Conditions: Familial Adenomatous Polyposis
• Interventions: Other: Electronic Health Record Review

• Registration Number: NCT04674228
• Lead Sponsor: National Cancer Institute (NCI)

Brief Summary

This study reviews post study clinical endoscopy reports in follow up to patients who participated in MAY2016-07-01 with weekly erlotinib for familial adenomatous polyposis. Reviewing follow up medical records may help researchers examine the extent of rapid progression of familiar adenomatous polyposis disease burden after discontinuation of weekly erlotinib.

Detailed Description

PRIMARY OBJECTIVE:

I. To review clinical endoscopy reports, pathology reports, and other medical records related to standard-of-care endoscopic evaluations for all participants in the parent study, MAY2016-07-01, to determine the extent of reports of rapid progression of recurrent polyps after completion intervention and follow up under the parent protocol.

OUTLINE:

Patients who participated in MAY2016-07-01 undergo review of medical records.

Study Timeline

• Study First Submitted: 2020-12-17
• Study First Submitted QC: 2020-12-17
• Study First Posted: 2020-12-19
• Study Start: 2021-05-07
• Primary Completion: 2021-10-28
• Study Completion: 2022-05-17
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-15
• Last Update Posted: 2022-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• MAY2016-07-01 study participants for whom medical records are available and accessible

Exclusion Criteria

• MAY2016-07-01 study participants who have opted out of medical records reviews or for whom consent for medical record review cannot be confirmed/documented

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational (medical record review)	Electronic Health Record Review	Patients who participated in MAY2016-07-01 undergo review of medical records.

Primary Outcome Measures

Name	Time	Method
Number of study participants exhibiting clinically significant progression of duodenal neoplasia after completion of study drug	At completion of study	Will be assessed by endoscopy.
Number of participants who underwent surgical resection	At completion of study	Will determine the number of participants who underwent surgical resection for management of advanced upper gastrointestinal (GI) neoplasia/cancer between the date of completion of intervention and 2/28/2021.
Number of participants who required endoscopic resection of advanced upper gastrointestinal (GI) neoplasms	At completion of study

Secondary Outcome Measures

Name	Time	Method
Number of participants with evidence of progression of upper GI disease	At completion of study	Will be calculated by increase in Spigelman stage.

Trial Locations

Locations (2)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States