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

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04674228

Enrollment

Registered

2020-12-19

Start date

2021-05-07

Completion date

2022-05-17

Last updated

2026-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Familial Adenomatous Polyposis

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.

Interventions

OTHERElectronic Health Record Review

Review of medical records

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORNiloy J Samadder

Mayo Clinic in Rochester

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 12, 2026