Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-26 @ 2:42 AM
Study NCT ID:
NCT01354002
Status:
RECRUITING
Last Update Posted:
2025-08-07
First Post:
2011-05-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Protocol for Collecting, Banking and Distributing Human Tissue Samples: St. Jude Children's Research Hospital Tissue Resources Core Facility
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': "Samples collected and processed from patients include any tumor or non-tumor sample, including blood, ascites, pleural effusion, bone marrow, solid tumors, brain tumors, tissue uninvolved by tumor, cerebrospinal fluid, and urine samples. Non-tumor samples are also collected and processed from patients' relatives and controls. Samples are processed under sterile conditions whenever possible, and tumor cells and tissues are cryopreserved viable. Cellular subfractions are also isolated including DNA, RNA, and protein."}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100000}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2050-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-05', 'studyFirstSubmitDate': '2011-05-09', 'studyFirstSubmitQcDate': '2011-05-12', 'lastUpdatePostDateStruct': {'date': '2025-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-05-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2050-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Collecting, processing and archiving human tissue', 'timeFrame': 'Samples will be stored indefinitely.', 'description': 'Human tissue and body fluids will be collected for use in research; The processing of samples helps to reduce duplication of technical effort, equipment, supplies, and laboratory space by investigators requiring human tissues for research'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['human biological samples', 'tissue banking'], 'conditions': ['Normal and Diseased Tissue and Body Fluids Samples']}, 'referencesModule': {'references': [{'pmid': '31604778', 'type': 'DERIVED', 'citation': 'Maciaszek JL, Oak N, Chen W, Hamilton KV, McGee RB, Nuccio R, Mostafavi R, Hines-Dowell S, Harrison L, Taylor L, Gerhardt EL, Ouma A, Edmonson MN, Patel A, Nakitandwe J, Pappo AS, Azzato EM, Shurtleff SA, Ellison DW, Downing JR, Hudson MM, Robison LL, Santana V, Newman S, Zhang J, Wang Z, Wu G, Nichols KE, Kesserwan CA. Enrichment of heterozygous germline RECQL4 loss-of-function variants in pediatric osteosarcoma. Cold Spring Harb Mol Case Stud. 2019 Oct 23;5(5):a004218. doi: 10.1101/mcs.a004218. Print 2019 Oct.'}], 'seeAlsoLinks': [{'url': 'http://www.stjude.org', 'label': "St. Jude Children's Research Hospital"}, {'url': 'http://www.stjude.org/protocols', 'label': 'Clinical Trials Open at St. Jude'}]}, 'descriptionModule': {'briefSummary': "The aims of this protocol are: to collect and store diseased and normal tissue and body fluid samples from new and returning patients at St. Jude Children's Research Hospital (SJCRH), affiliated sites and collaborating institutions; to collect and store samples from relatives of SJCRH patients; to collect and store retrospective and prospective pertinent corresponding clinical and laboratory data on disease characterization, treatment, and outcome; and to serve as a source of human biological samples and corresponding laboratory and clinical data.", 'detailedDescription': "There is no study design for this protocol. Samples obtained under IRB/IEC-approved protocols that clearly permit storage of patient material at SJCRH will be banked, provided proof of informed consent is available. Such samples will be tagged accordingly and will be only released to fulfill the aim(s) of the protocol under which they were obtained, or to investigators that apply to the St. Jude Children's Research Hospital Tissue Resources Committee to use the samples."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "All patients, their relatives, and control populations treated at St. Jude Children's Research Hospital (SJCRH), collaborating sites and affiliates.", 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients (and their relatives) and control populations treated or studied at SJCRH and SJCRH affiliates and collaborating sites that have IRB approval for TBANK with malignant and non-malignant conditions.\n* Patients from institutions that do not have Institutional Review Board (IRB) approval for TBANK, and at which a banking mechanism may not be established, who provide samples for research at St. Jude and from whom consent for TBANK is obtained by the TBANK principal investigator (PI).\n* Samples from employees of St. Jude Children's Research Hospital (SJCRH) collected for public health surveillance studies (e.g. SJTRC-NCT04362995) provided the employees have consented to participate in the specific IRB-approved studies.\n\nExclusion Criteria:\n\n* Patients from institutions that do not have IRB approval for TBANK, and who have not provided consent for TBANK, or patients not enrolled on SJCRH protocols that incorporate consent for tumor banking."}, 'identificationModule': {'nctId': 'NCT01354002', 'briefTitle': "Protocol for Collecting, Banking and Distributing Human Tissue Samples: St. Jude Children's Research Hospital Tissue Resources Core Facility", 'organization': {'class': 'OTHER', 'fullName': "St. Jude Children's Research Hospital"}, 'officialTitle': "TBANK: Protocol for Collecting, Banking and Distributing Human Tissue Samples: St. Jude Children's Research Hospital Tissue Resources Core Facility", 'orgStudyIdInfo': {'id': 'TBANK'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Protocol Participants', 'description': 'All participants enrolled on protocols'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35801', 'city': 'Huntsville', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Marla Daves, MD', 'role': 'CONTACT', 'email': 'Marla.Daves@hhsys.org', 'phone': '256-265-5833'}, {'name': 'Marla Daves, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'St. Jude Clinic at Huntsville Hospital for Women & Children', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '94305', 'city': 'Palo Alto', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Norman J. Lacayo, MD', 'role': 'CONTACT', 'email': 'lacayon@stanford.edu', 'phone': '650-723-5535'}, {'name': 'Norman J. Lacayo, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Lucile Packard Children's Hospital Stanford University", 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Deborah Schiff, MD', 'role': 'CONTACT', 'phone': '858-966-5983'}, {'name': 'Deborah Schiff, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Rady Children's Hospital and Health Center", 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '61637', 'city': 'Peoria', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mary Beth Ross, MD', 'role': 'CONTACT', 'phone': '309-624-4945'}, {'name': 'Mary Beth Ross, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Children's Hospital of Illinois at OSF-Saint Francis Medical Center", 'geoPoint': {'lat': 40.69365, 'lon': -89.58899}}, {'zip': '70808', 'city': 'Baton Rouge', 'state': 'Louisiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jeffrey Deyo, MD', 'role': 'CONTACT', 'phone': '225-763-6337'}, {'name': 'Jeffrey Deyo, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Our Lady of the Lake Regional Medical Center', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}, {'zip': '71130-3932', 'city': 'Shreveport', 'state': 'Louisiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ayobami Olanrewaju, MBBS', 'role': 'CONTACT', 'email': 'Ayobami.Olanrewaju@lsuhs.edu', 'phone': '318-626-0772'}, {'name': 'Ayobami Olanrewaju, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Louisiana State University Health Sciences Center', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'status': 'SUSPENDED', 'country': 'United States', 'facility': "Children's Hospital of Michigan", 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '65804', 'city': 'Springfield', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Francisca R. Fasipe, MD', 'role': 'CONTACT', 'phone': '877-700-2110'}, {'name': 'Francisca R. Fasipe, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Mercy Children's Hospital - Springfield", 'geoPoint': {'lat': 37.21533, 'lon': -93.29824}}, {'zip': '28204', 'city': 'Charlotte', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Christine Bolen, MD', 'role': 'CONTACT', 'email': 'Cybolen@novanthealth.org', 'phone': '704-384-1900'}, {'name': 'Christine Bolen, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "St. Jude Affiliate Clinic at Novant Health Hemby Children's Hospital", 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '74136', 'city': 'Tulsa', 'state': 'Oklahoma', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ashraf Mohamed, MD, MHA, PhD', 'role': 'CONTACT', 'email': 'AmMohamed@saintfrancis.com', 'phone': '918-851-1924'}, {'name': 'Ashraf Mohamed, MD, MHA, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "St. Jude Affiliate Clinic at Saint Francis Children's Hospital", 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}, {'zip': '37604', 'city': 'Johnson City', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Marcela Popescu, MD', 'role': 'CONTACT', 'phone': '423-431-3950'}, {'name': 'Marcela Popescu, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Johnson City Medical Center', 'geoPoint': {'lat': 36.31344, 'lon': -82.35347}}, {'zip': '38103', 'city': 'Memphis', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Charles Mullighan, MBBS, MD', 'role': 'CONTACT', 'phone': '901-287-5437'}, {'name': 'Charles Mullighan, MBBS, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "LeBonheur Children's Hospital", 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '38105', 'city': 'Memphis', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Charles Mulligan, MBBS, MD', 'role': 'CONTACT', 'email': 'referralinfo@stjude.org', 'phone': '866-278-5833'}, {'name': 'Charles Mullighan, MBBS, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "St. Jude Children's Research Hospital", 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '76104', 'city': 'Fort Worth', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kenneth M. Heym, MD', 'role': 'CONTACT', 'phone': '682-885-4007'}, {'name': 'Kenneth M. Heym, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Cook Children's Medical Center", 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}], 'centralContacts': [{'name': 'Charles Mullighan, MBBS, MD', 'role': 'CONTACT', 'email': 'charles.mullighan@stjude.org', 'phone': '901-595-3387'}], 'overallOfficials': [{'name': 'Charles Mullighan, MBBS, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St. Jude Children's Research Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "St. Jude Children's Research Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}