NCT04674228

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

Review of Post-Study Clinical Endoscopy Reports in Follow Up to MAY2016-07-01 Weekly Erlotinib for Familial Adenomatous Polyposis

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 42 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Familial Adenomatous Polyposis

Interventions

Type	Name	Description
OTHER	Electronic Health Record Review	Review of medical records

Timeline

• Start date: 2021-05-07
• Primary completion: 2021-10-28
• Completion: 2022-05-17
• First posted: 2020-12-19
• Last updated: 2022-06-16

Locations

2 sites across 1 country: United States