Ignite Creation Date:
2025-12-26 @ 4:04 PM
Ignite Modification Date:
2026-02-24 @ 10:54 AM
Study NCT ID:
NCT03610906
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-03-07
First Post:
2018-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Pilot Study Identifying Clinically Relevant Biological Targets for Medical Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003397', 'term': 'Craniopharyngioma'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D047368', 'term': 'Tumor Burden'}], 'ancestors': [{'id': 'D001837', 'term': 'Body Weights and Measures'}, {'id': 'D000886', 'term': 'Anthropometry'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Brain tissue and/or cyst fluid, blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2019-03-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2030-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-04', 'studyFirstSubmitDate': '2018-07-17', 'studyFirstSubmitQcDate': '2018-07-25', 'lastUpdatePostDateStruct': {'date': '2025-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-02-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Identification of Potential Therapeutic Targets', 'timeFrame': 'Beginning of study to end of study, up to 1 year.', 'description': 'Investigators will identify potential therapeutic targets through mRNA expression.'}, {'measure': 'Identification of Potential Therapeutic Targets', 'timeFrame': 'Beginning of study to end of study, up to 1 year.', 'description': 'Investigators will identify potential therapeutic targets through microarray analysis.'}, {'measure': 'Identification of Potential Therapeutic Targets', 'timeFrame': 'Beginning of study to end of study, up to 1 year.', 'description': 'Investigators will identify potential therapeutic targets immunohistochemistry.'}, {'measure': 'Identification of Potential Therapeutic Targets', 'timeFrame': 'Beginning of study to end of study, up to 1 year.', 'description': 'Investigators will identify potential therapeutic targets through quantitative PCR.'}, {'measure': 'Identification of Potential Therapeutic Targets', 'timeFrame': 'Beginning of study to end of study, up to 1 year.', 'description': 'Investigators will also perform immunostaining for beta-catenin and use DNA SNaPshot analysis to determine what parts of the tumor are responsible for observed gene signatures.'}], 'secondaryOutcomes': [{'measure': 'Survival', 'timeFrame': 'Beginning of study up to age 21 or death, whichever comes first.', 'description': 'The amount of time the patient survives with or without the disease.'}, {'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'Beginning of study up to age 21 or death, whichever comes first.', 'description': 'The amount of time the patient survives without advancement of disease.'}, {'measure': 'Visual Deficit Assessment', 'timeFrame': 'At 6 and 12 months after the specimen sample was taken.', 'description': 'With regard to visual deficits, investigators will compare the rates of functional blindness, unilateral blindness, and visual field deficit.'}, {'measure': 'Pituitary Function Assessment', 'timeFrame': 'At 6 and 12 months after the specimen sample was taken.', 'description': 'With regard to pituitary function, investigators will assess patients based on the quality of life impairment that is associated with their dysfunction. Assessment will be divided among 4 groups:\n\n1. No dependence on hormone supplementation or evidence of diabetes insipidus\n2. Dependence on 1 or 2 hormone supplements without diabetes insipidus\n3. The presence of diabetes insipidus with or without the need for 2 or fewer hormone supplements\n4. Diabetes Insipidus with panhypopituitarism'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pilot Study', 'Biological Targets', 'CTNNB1', 'Tumor'], 'conditions': ['Craniopharyngioma, Child']}, 'descriptionModule': {'briefSummary': 'New data suggests that the current treatment for pediatric adamantinomatous craniopharyngioma (CPA) may not be as effective as it could be.', 'detailedDescription': 'Current treatment regimens for pediatric CPA are limited to surgery and radiation therapy. This pilot study seeks to identify biologically rational therapeutics for the medical treatment of adamantinomatous CPA by confirming the overexpression of specific molecules.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '30 Days', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The population to be enrolled in this study will be children ages 0 through 21 years of age with a high preoperative suspicion of craniopharyngioma. The study population will be selected from the clinics at the 10 POETIC member institutions, and selected additional institutions by the treating clinicians.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients between 0-21 years of age.\n2. Patients with the diagnosis or clinical suspicion of craniopharyngioma in whom planned clinical management will include tissue sampling.\n\nExclusion Criteria:\n\n1. Patients in whom final pathology does not demonstrate adamantinomatous craniopharyngioma\n2. Patients in whom tissue specimen is not obtained/available\n3. Patients over 21 years of age.\n4. Patients who choose not to participate'}, 'identificationModule': {'nctId': 'NCT03610906', 'briefTitle': 'Prospective Pilot Study Identifying Clinically Relevant Biological Targets for Medical Therapy', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'Advancing Treatment for Pediatric Craniopharyngioma: Prospective Pilot Study Identifying Clinically Relevant Biological Targets for Medical Therapy', 'orgStudyIdInfo': {'id': '14-0426.cc'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pediatrics with Tumors', 'description': 'Pediatrics who have a tumor specimen that is suspected to be craniopharyngioma, but is deemed superfluous to the clinical care of the patient (e.g. pathological diagnosis).', 'interventionNames': ['Procedure: Tumor and Blood Specimens']}], 'interventions': [{'name': 'Tumor and Blood Specimens', 'type': 'PROCEDURE', 'description': 'If available, specimen will be sampled from within the tumor, and not include portions of the tumor capsule. If the tumor includes a cyst, fluid from the cyst will be sampled if available. For each tumor specimen, a companion sample of blood that would otherwise be disposed of through usual clinical practice in the operating room will also be collected.', 'armGroupLabels': ['Pediatrics with Tumors']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': "Children's Hospital Colorado", 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}], 'overallOfficials': [{'name': 'Todd Hankinson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}