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

Familial Adenomatous Polyposis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04674228
• Other study ID #: NCI-2020-13238
• Secondary ID: NCI-2020-13238N0
• Status: Completed
• Start date: May 7, 2021
• Est. completion date: May 17, 2022

Study information

• Verified date: June 2022
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: May 17, 2022
• Est. primary completion date: October 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Adenomatous Polyposis Coli
• Familial Adenomatous Polyposis

Intervention

Other:
• Electronic Health Record Review
Review of medical records

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of study participants exhibiting clinically significant progression of duodenal neoplasia after completion of study drug	Will be assessed by endoscopy.	At completion of study
Primary	Number of participants who underwent surgical resection	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.	At completion of study
Primary	Number of participants who required endoscopic resection of advanced upper gastrointestinal (GI) neoplasms		At completion of study
Secondary	Number of participants with evidence of progression of upper GI disease	Will be calculated by increase in Spigelman stage.	At completion of study