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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04674228
Recruitment Status : Completed
First Posted : December 19, 2020
Last Update Posted : June 16, 2022
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment
Familial Adenomatous Polyposis 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.

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Study Type : Observational
Actual Enrollment : 42 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Review of Post-Study Clinical Endoscopy Reports in Follow Up to MAY2016-07-01 Weekly Erlotinib for Familial Adenomatous Polyposis
Actual Study Start Date : May 7, 2021
Actual Primary Completion Date : October 28, 2021
Actual Study Completion Date : May 17, 2022


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




Primary Outcome Measures :
  1. Number of study participants exhibiting clinically significant progression of duodenal neoplasia after completion of study drug [ Time Frame: At completion of study ]
    Will be assessed by endoscopy.

  2. Number of participants who underwent surgical resection [ Time Frame: 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.

  3. Number of participants who required endoscopic resection of advanced upper gastrointestinal (GI) neoplasms [ Time Frame: At completion of study ]

Secondary Outcome Measures :
  1. Number of participants with evidence of progression of upper GI disease [ Time Frame: At completion of study ]
    Will be calculated by increase in Spigelman stage.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04674228


Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
United States, Texas
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Niloy J Samadder Mayo Clinic in Rochester
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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT04674228    
Other Study ID Numbers: NCI-2020-13238
NCI-2020-13238 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
N01-CN-2012-00042
MAY2016-07-01F ( Other Identifier: Mayo Clinic in Rochester )
MAY2016-07-01F ( Other Identifier: DCP )
N01CN00042 ( U.S. NIH Grant/Contract )
P30CA015083 ( U.S. NIH Grant/Contract )
First Posted: December 19, 2020    Key Record Dates
Last Update Posted: June 16, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
URL: https://grants.nih.gov/policy/sharing.htm
Additional relevant MeSH terms:
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Adenomatous Polyposis Coli
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Adenomatous Polyps
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplastic Syndromes, Hereditary
Intestinal Polyposis
Genetic Diseases, Inborn