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

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.

Study Overview

• Status: Completed
• Conditions: Familial Adenomatous Polyposis
• Intervention / Treatment: Other: Electronic Health Record Review

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.

• Study Type: Observational
• Enrollment (Actual): 42

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester
  • Texas
    • Houston, Texas, United States, 77030
      • M D Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants in MAY2016-07-01 Phase II Trial of Weekly Erlotinib Dosing to Reduce Duodenal Polyp Burden Associated with Familial Adenomatous Polyposis

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Observational (medical record review); Patients who participated in MAY2016-07-01 undergo review of medical records.	Other: Electronic Health Record Review; Review of medical records

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Niloy J Samadder, Mayo Clinic in Rochester

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2021
• Primary Completion (Actual): October 28, 2021
• Study Completion (Actual): May 17, 2022

Study Registration Dates

• First Submitted: December 17, 2020
• First Submitted That Met QC Criteria: December 17, 2020
• First Posted (Actual): December 19, 2020

Study Record Updates

• Last Update Posted (Actual): June 16, 2022
• Last Update Submitted That Met QC Criteria: June 15, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Genetic Diseases, Inborn; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Colorectal Neoplasms; Neoplastic Syndromes, Hereditary; Adenomatous Polyps; Adenoma; Intestinal Polyposis; Adenomatous Polyposis Coli
• Other Study ID Numbers: NCI-2020-13238 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); P30CA015083 (U.S. NIH Grant/Contract); N01-CN-2012-00042; N01CN00042 (U.S. NIH Grant/Contract); MAY2016-07-01F (Other Identifier: DCP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.