Ignite Creation Date:
2025-12-24 @ 9:49 PM
Ignite Modification Date:
2026-04-25 @ 12:14 AM
Study NCT ID:
NCT04432532
Status:
WITHDRAWN
Last Update Posted:
2025-02-10
First Post:
2020-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neuroendocrine and Adrenal Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D000310', 'term': 'Adrenal Gland Neoplasms'}], 'ancestors': [{'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D000307', 'term': 'Adrenal Gland Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Tumor specimens, blood and/or saliva samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'whyStopped': 'Change in research direction', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2028-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-06', 'studyFirstSubmitDate': '2020-03-09', 'studyFirstSubmitQcDate': '2020-06-12', 'lastUpdatePostDateStruct': {'date': '2025-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival', 'timeFrame': '10 years'}], 'secondaryOutcomes': [{'measure': 'Tumor Recurrence', 'timeFrame': '10 years', 'description': 'We want to record recurrences in our patient population'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neuroendocrine Tumors', 'Adrenal Tumor']}, 'descriptionModule': {'briefSummary': 'This is a prospective study of rare neuroendocrine and adrenal tumors. Subjects will be enrolled via informed consent, and blood and/or saliva and tissue will be collected. This is designed to work in conjunction with IRB#831990 which is a retrospective protocol. The University of Pennsylvania will be a contributing site with the University of Michigan as the coordinating site for the A5 alliance, a multi-institutional collaborative designed to study neuroendocrine and adrenal tumors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed and seeking treatment for neuroendocrine tumors or adrenal tumors', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosed with neuroendocrine and/or an adrenal tumor\n\nExclusion Criteria:\n\n* pregnant women\n* prisoners\n* people under the age of 18'}, 'identificationModule': {'nctId': 'NCT04432532', 'acronym': 'NETAT', 'briefTitle': 'Neuroendocrine and Adrenal Tumors', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'Neuroendocrine and Adrenal Tumors: Biochemical, Histopathologic and Genetic Studies', 'orgStudyIdInfo': {'id': '832475'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Neuroendocrine Tumor', 'interventionNames': ['Other: No intervention']}, {'label': 'Adrenal Tumor', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'There are no interventions', 'armGroupLabels': ['Adrenal Tumor', 'Neuroendocrine Tumor']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Surgery', 'investigatorFullName': 'Heather Wachtel, MD', 'investigatorAffiliation': 'University of Pennsylvania'}}}}