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| ID | Type | Description | Link |
|---|---|---|---|
| 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 | View source | |
| P30CA015083 | U.S. NIH Grant/Contract | View source |
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This particular part of the study could not be completed as endoscopy reports post completion of erlotinib trial were distributed across community and other hos
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational (medical record review) | Patients who participated in MAY2016-07-01 undergo review of medical records. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electronic Health Record Review | Other | Review of medical records |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Participants in MAY2016-07-01 Phase II Trial of Weekly Erlotinib Dosing to Reduce Duodenal Polyp Burden Associated with Familial Adenomatous Polyposis
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| Name | Affiliation | Role |
|---|---|---|
| Niloy J Samadder | Mayo Clinic in Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States | ||
| M D Anderson Cancer Center |
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.
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| ID | Term |
|---|---|
| D011125 | Adenomatous Polyposis Coli |
| ID | Term |
|---|---|
| D018256 | Adenomatous Polyps |
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| Houston |
| Texas |
| 77030 |
| United States |
| D009369 | Neoplasms |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009386 | Neoplastic Syndromes, Hereditary |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D044483 | Intestinal Polyposis |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |