Ignite Creation Date:
2025-12-25 @ 5:02 AM
Ignite Modification Date:
2026-01-26 @ 12:22 PM
Study NCT ID:
NCT05120518
Status:
RECRUITING
Last Update Posted:
2024-11-12
First Post:
2021-11-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post Mortem Tissue Donation of Pediatric Tumor Tissues and Cells
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': "Tissue will be collected through a research tissue collection autopsy of the original tumor and other sites that are appropriate. Both tumor and normal cells will be collected during autopsy in addition to body fluids such cerebrospinal fluid (CSF), blood, bone marrow and skin biopsies for genomic testing.\n\nFor brain tumor bio-specimens, through CBTN, we will store, analyze and share a large cohort of samples and within the repository protocol annotate and characterize using the latest genomic technologies. The information and materials collected will be used to support cross-disciplinary collaborations and coordinated research projects, focused on the molecular and cellular origins of children's tumors."}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-08-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2029-08-14', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-08', 'studyFirstSubmitDate': '2021-11-03', 'studyFirstSubmitQcDate': '2021-11-03', 'lastUpdatePostDateStruct': {'date': '2024-11-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-08-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Procurement of pediatric cancer and non-cancer tumor tissue during autopsy with signed consent', 'timeFrame': 'Up to 5 years from procurement', 'description': 'Procurement of pediatric cancer and non-cancer tumor tissue during autopsy with signed consent. Tissue will be collected through a research tissue collection autopsy of the original tumor and other sites that are appropriate. Samples of both tumor and normal cells will be collected in addition to body fluids such as cerebrospinal fluid (CSF), blood, bone marrow, and skin biopsies for genomic testing.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pediatric Cancer']}, 'referencesModule': {'references': [{'pmid': '23433673', 'type': 'BACKGROUND', 'citation': "Baker JN, Windham JA, Hinds PS, Gattuso JS, Mandrell B, Gajjar P, West NK, Hammarback T, Broniscer A. Bereaved parents' intentions and suggestions about research autopsies in children with lethal brain tumors. J Pediatr. 2013 Aug;163(2):581-6. doi: 10.1016/j.jpeds.2013.01.015. Epub 2013 Feb 19."}, {'pmid': '20589749', 'type': 'BACKGROUND', 'citation': 'Broniscer A, Baker JN, Baker SJ, Chi SN, Geyer JR, Morris EB, Gajjar A. Prospective collection of tissue samples at autopsy in children with diffuse intrinsic pontine glioma. Cancer. 2010 Oct 1;116(19):4632-7. doi: 10.1002/cncr.25405.'}, {'pmid': '24309611', 'type': 'BACKGROUND', 'citation': 'Wiener L, Sweeney C, Baird K, Merchant MS, Warren KE, Corner GW, Roberts KE, Lichtenthal WG. What do parents want to know when considering autopsy for their child with cancer? J Pediatr Hematol Oncol. 2014 Aug;36(6):464-70. doi: 10.1097/MPH.0000000000000078.'}, {'pmid': '23015377', 'type': 'BACKGROUND', 'citation': 'Alabran JL, Hooper JE, Hill M, Smith SE, Spady KK, Davis LE, Peterson LS, Malempati S, Ryan CW, Acosta R, Spunt SL, Keller C. Overcoming autopsy barriers in pediatric cancer research. Pediatr Blood Cancer. 2013 Feb;60(2):204-9. doi: 10.1002/pbc.24320. Epub 2012 Sep 26.'}, {'type': 'BACKGROUND', 'citation': 'Meeting Minutes: Enhancing Biobanking for Childhood Cancers, NCI, May 13, 2019'}], 'seeAlsoLinks': [{'url': 'http://www.cancer.gov', 'label': 'Related Info'}, {'url': 'http://genome.gov', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to utilize all donated pediatric tumor tissues and cells obtained from autopsy to prospectively develop novel patient derived orthotopic xenograft (PDOX) mouse models as well as in vitro cell culture model systems for pediatric cancers, and also provide tissue samples to other researchers and organizations (eg, CBTN, DIPG Registry, COG).', 'detailedDescription': 'The objective of this study is to utilize all donated pediatric tumor tissues and cells obtained from autopsy to prospectively develop novel patient derived orthotopic xenograft (PDOX) mouse models as well as in vitro cell culture model systems for pediatric cancers, and also provide tissue samples to other researchers and organizations (eg, CBTN, DIPG Registry, COG).\n\nThis model system will then be subjected to 1) comprehensive histopathological and molecular characterizations during serial in vivo sub-transplantations; 2) cryopreserved for long term preservation of tumorigenicity; and 3) used for future biological studies and preclinical drug testing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pediatric patients with cancer and non-cancer tumor types (solid, liquid, neuro-oncology)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pediatric patients with cancer and non-cancer tumor types (solid, liquid, neuro-oncology)\n* Signed consent for post mortem tissue donation and autopsy\n\nExclusion Criteria:\n\n* Signed consent for post mortem tissue donation and autopsy not obtained'}, 'identificationModule': {'nctId': 'NCT05120518', 'briefTitle': 'Post Mortem Tissue Donation of Pediatric Tumor Tissues and Cells', 'organization': {'class': 'OTHER', 'fullName': "Ann & Robert H Lurie Children's Hospital of Chicago"}, 'officialTitle': 'Post Mortem Tissue Donation of Pediatric Tumor Tissues and Cells', 'orgStudyIdInfo': {'id': '2019-2982'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pediatric patients with cancer and non-cancer tumor types', 'description': 'Pediatric patients with cancer and non-cancer tumor types (solid, liquid, neuro-oncology and stem cell)', 'interventionNames': ['Other: Collection of post mortem tissue donation']}], 'interventions': [{'name': 'Collection of post mortem tissue donation', 'type': 'OTHER', 'description': 'Collection of post mortem tissue from pediatric participants with cancer and non-cancer tumor types from whom post mortem tissue donation and autopsy consent is obtained.', 'armGroupLabels': ['Pediatric patients with cancer and non-cancer tumor types']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Angela Waanders, MD', 'role': 'CONTACT', 'email': 'awaanders@luriechildrens.org', 'phone': '312-227-4090'}, {'name': 'Melissa Williams, BA', 'role': 'CONTACT', 'email': 'mjwilliams@luriechildrens.org', 'phone': '312-227-3893'}], 'facility': "Ann & Robert H. Lurie Children's Hospital of Chicago", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'centralContacts': [{'name': 'Angela Waanders, MD', 'role': 'CONTACT', 'email': 'awaanders@luriechildrens.org', 'phone': '312-227-4090'}, {'name': 'Melissa Williams, BA', 'role': 'CONTACT', 'email': 'mjwilliams@luriechildrens.org', 'phone': '312-227-3893'}], 'overallOfficials': [{'name': 'Angela Waanders, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Ann & Robert H Lurie Children's Hospital of Chicago"}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'Starting August 2019', 'ipdSharing': 'YES', 'description': 'To provide samples and PHI to CBTN. Samples and data will be de-identified prior to placement in the CBTN Biorepository.', 'accessCriteria': 'The IPD for this study will be stored in the CBTN Biorepository. Samples and data will be de-identified prior to placement in the CBTN Biorepository. Researchers who have been granted access to the CBTN Biorepository will have access to the IPD for this study.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Ann & Robert H Lurie Children's Hospital of Chicago", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Angela Waanders', 'investigatorAffiliation': "Ann & Robert H Lurie Children's Hospital of Chicago"}}}}