Review of Post-Study Clinical Endoscopy Reports in Follow Up to MAY2016-07-01
5 other identifiers
observational
42
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2021
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 17, 2020
CompletedFirst Posted
Study publicly available on registry
December 19, 2020
CompletedStudy Start
First participant enrolled
May 7, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 28, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 17, 2022
CompletedJune 16, 2022
June 1, 2022
6 months
December 17, 2020
June 15, 2022
Conditions
Outcome Measures
Primary Outcomes (3)
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
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
Number of participants who required endoscopic resection of advanced upper gastrointestinal (GI) neoplasms
At completion of study
Secondary Outcomes (1)
Number of participants with evidence of progression of upper GI disease
At completion of study
Study Arms (1)
Observational (medical record review)
Patients who participated in MAY2016-07-01 undergo review of medical records.
Interventions
Eligibility Criteria
Participants in MAY2016-07-01 Phase II Trial of Weekly Erlotinib Dosing to Reduce Duodenal Polyp Burden Associated with Familial Adenomatous Polyposis
You may qualify if:
- MAY2016-07-01 study participants for whom medical records are available and accessible
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
M D Anderson Cancer Center
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Niloy J Samadder
Mayo Clinic in Rochester
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 17, 2020
First Posted
December 19, 2020
Study Start
May 7, 2021
Primary Completion
October 28, 2021
Study Completion
May 17, 2022
Last Updated
June 16, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will share
NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.