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

National Cancer Institute (NCI)

Status: Completed

Conditions: Familial Adenomatous Polyposis

Treatments: Other: Electronic Health Record Review

Study type: Observational

Funder types: NIH

Identifiers

NCT04674228

P30CA015083 (U.S. NIH Grant/Contract)

NCI-2020-13238 (Registry Identifier)

MAY2016-07-01F (Other Identifier)

N01-CN-2012-00042

N01CN00042 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

42 participants in 1 patient group

Observational (medical record review)

Description:

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

Treatment:

Other: Electronic Health Record Review