Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-26 @ 12:05 AM
Study NCT ID:
NCT00433394
Status:
COMPLETED
Last Update Posted:
2013-06-27
First Post:
2007-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Registration and Informed Consent Study for the Childhood Cancer Research Network
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D018479', 'term': 'Early Intervention, Educational'}], 'ancestors': [{'id': 'D002662', 'term': 'Child Health Services'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D011314', 'term': 'Preventive Health Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2242}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-26', 'studyFirstSubmitDate': '2007-02-09', 'studyFirstSubmitQcDate': '2007-02-09', 'lastUpdatePostDateStruct': {'date': '2013-06-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-02-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Informed consent collection to register with the Childhood Cancer Research Network'}, {'measure': 'Informed consent collection for possible participation in future non-therapeutic research studies'}, {'measure': 'Facilitation of systematic registration into the Childhood Cancer Research Network'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['unspecified childhood solid tumor, protocol specific'], 'conditions': ['Unspecified Childhood Solid Tumor, Protocol Specific']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Collecting informed consent from parents of children with cancer to register with the Childhood Cancer Research Network may help the study of cancer in the future.\n\nPURPOSE: This study is collecting informed consent to register younger patients with cancer into the Childhood Cancer Research Network.', 'detailedDescription': "OBJECTIVES:\n\n* Obtain informed consent from parents (and the child, when appropriate) of children diagnosed with cancer (who are under 21 years of age) to register their child's name and address with the Childhood Cancer Research Network.\n* Obtain informed consent from parents (and the child, when appropriate) of children diagnosed with cancer (who are under 21 years of age) to be contacted in the future for possible participation in non-therapeutic research studies involving the parents and/or child.\n* Facilitate the systematic registration of pediatric and adolescent patients diagnosed with cancer into the Childhood Cancer Research Network.\n\nOUTLINE: Consent is obtained from parents (and pediatric patients, where applicable) to register the patient's and parent's names and addresses with the Childhood Cancer Research Network, provide a copy of the pathology report to the Network, and contact parents in the future for possible non-therapeutic research studies involving the parents and/or child.\n\nInformation provided will be held in strict confidence.\n\nPROJECTED ACCRUAL: Not specified"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Child (\\< 21 years of age) with newly diagnosed cancer\n\nPATIENT CHARACTERISTICS:\n\n* Not specified\n\nPRIOR CONCURRENT THERAPY:\n\n* Not specified'}, 'identificationModule': {'nctId': 'NCT00433394', 'briefTitle': 'Registration and Informed Consent Study for the Childhood Cancer Research Network', 'nctIdAliases': ['NCT00228709'], 'organization': {'class': 'NETWORK', 'fullName': "Children's Oncology Group"}, 'officialTitle': 'Protocol for Registration and Consent to the Childhood Cancer Research Network - A Limited Institution Pilot', 'orgStudyIdInfo': {'id': 'AADM01P1'}, 'secondaryIdInfos': [{'id': 'COG-AADM01P1', 'type': 'OTHER', 'domain': "Children's Oncology Group"}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stratum 1: No Consent for personal identification', 'description': 'Data to be collected for this stratum include histology, primary site, treating hospital, and institutional principal investigator. Data will be coded using the North American Association for Central Cancer Registries (N.A.A.C.C.R.) data standards for cancer registries.', 'interventionNames': ['Procedure: educational intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Stratum 2: Consent for personal identification - No Contact', 'description': "Data will be collected for this study include:child's name, parent's name, address, telephone number, child's date of birth, race, ethnicity, histology, primary site, treating hospital, and institutional principal investigator. Data will be coded using the North American Association for Central Cancer Registries (N.A.A.C.C.R.) data standards for cancer registries. No contact for future to ask me to consider taking part in Research Network approved studies", 'interventionNames': ['Procedure: cancer prevention intervention', 'Procedure: educational intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Stratum 3: Consent for personal identification - Contact', 'description': "Data will be collected for this study include:child's name, parent's name, address, telephone number, child's date of birth, race, ethnicity, histology, primary site, treating hospital, and institutional principal investigator. Data will be coded using the North American Association for Central Cancer Registries (N.A.A.C.C.R.) data standards for cancer registries Someone from the Childhood Cancer Research Network may contact me in the future to ask me to consider taking part in Research Network approved studies", 'interventionNames': ['Procedure: cancer prevention intervention', 'Procedure: educational intervention']}], 'interventions': [{'name': 'cancer prevention intervention', 'type': 'PROCEDURE', 'armGroupLabels': ['Stratum 2: Consent for personal identification - No Contact', 'Stratum 3: Consent for personal identification - Contact']}, {'name': 'educational intervention', 'type': 'PROCEDURE', 'armGroupLabels': ['Stratum 1: No Consent for personal identification', 'Stratum 2: Consent for personal identification - No Contact', 'Stratum 3: Consent for personal identification - Contact']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90801', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': "Jonathan Jaques Children's Cancer Center at Miller Children's Hospital", 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '06360-2875', 'city': 'Farmington', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center', 'geoPoint': {'lat': 41.71982, 'lon': -72.83204}}, {'zip': '33901', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'Lee Cancer Care of Lee Memorial Health System', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '32610-0232', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida Shands Cancer Center', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '95813', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Cancer Research Center of Hawaii', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '60068-1174', 'city': 'Park Ridge', 'state': 'Illinois', 'country': 'United States', 'facility': 'Advocate Lutheran General Cancer Care Center', 'geoPoint': {'lat': 42.01114, 'lon': -87.84062}}, {'zip': '48910', 'city': 'Lansing', 'state': 'Michigan', 'country': 'United States', 'facility': 'Breslin Cancer Center at Ingham Regional Medical Center', 'geoPoint': {'lat': 42.73253, 'lon': -84.55553}}, {'zip': '55404', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': "Children's Hospitals and Clinics of Minneapolis", 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '03756-0002', 'city': 'Lebanon', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}, {'zip': '07601', 'city': 'Hackensack', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Hackensack University Medical Center Cancer Center', 'geoPoint': {'lat': 40.88593, 'lon': -74.04347}}, {'zip': '12208-3419', 'city': 'Albany', 'state': 'New York', 'country': 'United States', 'facility': 'Albany Medical Center Hospital', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Cancer Institute at New York University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '28801', 'city': 'Asheville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Mission Hospitals - Memorial Campus', 'geoPoint': {'lat': 35.60095, 'lon': -82.55402}}, {'zip': '45404-1815', 'city': 'Dayton', 'state': 'Ohio', 'country': 'United States', 'facility': "Children's Medical Center - Dayton", 'geoPoint': {'lat': 39.75895, 'lon': -84.19161}}, {'zip': '44501', 'city': 'Youngstown', 'state': 'Ohio', 'country': 'United States', 'facility': "Tod Children's Hospital - Forum Health", 'geoPoint': {'lat': 41.09978, 'lon': -80.64952}}, {'zip': '19134-1095', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "St. Christopher's Hospital for Children", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '37916', 'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'facility': "East Tennessee Children's Hospital", 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}, {'zip': '78466', 'city': 'Corpus Christi', 'state': 'Texas', 'country': 'United States', 'facility': "Driscoll Children's Hospital", 'geoPoint': {'lat': 27.80058, 'lon': -97.39638}}, {'zip': '05405', 'city': 'Burlington', 'state': 'Vermont', 'country': 'United States', 'facility': 'Fletcher Allen Health Care - University Health Center Campus', 'geoPoint': {'lat': 44.47588, 'lon': -73.21207}}, {'zip': 'T6G 1Z2', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Alberta Hospital', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'H3H 1P3', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': "Montreal Children's Hospital at McGill University Health Center", 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Julie A. Ross, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Masonic Cancer Center, University of Minnesota'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Oncology Group", 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}