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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

42 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-07

Study Completion Date

2022-05-17

Brief Summary

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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.

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Detailed Description

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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

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Familial Adenomatous Polyposis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Observational (medical record review)

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

Electronic Health Record Review

Intervention Type OTHER

Review of medical records

Interventions

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Electronic Health Record Review

Review of medical records

Intervention Type OTHER

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No