Ignite Creation Date:
2025-12-26 @ 3:58 PM
Ignite Modification Date:
2025-12-29 @ 6:42 AM
Study NCT ID:
NCT04511806
Status:
RECRUITING
Last Update Posted:
2025-10-29
First Post:
2020-08-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Childhood Cancer Predisposition Study (CCPS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012042', 'term': 'Registries'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D011996', 'term': 'Records'}, {'id': 'D009934', 'term': 'Organization and Administration'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'From the Primary Subjects:\n\n\\- Germline DNA (required), serial blood and stool samples (optional)\n\nFrom Parents and siblings\n\n\\- Germline DNA (required).'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1050}, 'targetDuration': '10 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-04-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2030-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-27', 'studyFirstSubmitDate': '2020-08-11', 'studyFirstSubmitQcDate': '2020-08-11', 'lastUpdatePostDateStruct': {'date': '2025-10-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Establish and maintain a framework for recruitment, participation, and surveillance of children with cancer predisposition syndromes (CPS) in clinical and translational research studies.', 'timeFrame': 'Up to 10 years', 'description': 'This multicenter registry and biorepository will be developed with the purpose of studying individuals at high risk for childhood cancer to improve care and outcomes for pediatric patients with cancer and those with cancer predisposition syndromes (CPS).'}, {'measure': 'Define the natural history of disease in children with CPS.', 'timeFrame': 'Up to 10 years', 'description': 'To define the natural history of disease in children with CPS.'}, {'measure': 'Evaluate the clinical impact and effectiveness of standard and emerging tumor surveillance strategies.', 'timeFrame': 'Up to 10 years', 'description': 'Evaluate the clinical impact and effectiveness of standard and emerging tumor surveillance strategies to improve care and outcomes for pediatric patients with cancer and those with cancer predisposition syndromes (CPS).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cancer predisposition'], 'conditions': ['Pediatric Cancer']}, 'descriptionModule': {'briefSummary': 'The Childhood Cancer Predisposition Study (CCPS) is a multi-center, longitudinal, observational study that will collect clinical and biological data and specimens from children with a cancer predisposition syndromes (CPS) and their relatives.\n\nThe central hypothesis is that studying individuals at high risk for childhood cancer creates a unique opportunity for improving the understanding of carcinogenesis, tumor surveillance, early detection, and cancer prevention, which will collectively contribute to improving care and outcomes for pediatric patients with cancer and those with cancer predisposition syndromes (CPS).', 'detailedDescription': "The CCPS is designed as a multi-center, longitudinal, observational study that will collect clinical and biological data and specimens from children with a CPS and their relatives. The investigators plan to:\n\n1. Establish and maintain a framework for recruitment, participation, and surveillance of children with cancer predisposition syndromes (CPS) in clinical and translational research studies;\n2. Define the natural history of disease in children with CPS; and\n3. Evaluate the clinical impact and effectiveness of standard and emerging tumor surveillance strategies.\n\nThe study will enroll approximately 350 Children and 700 Relatives per year. The investigators plan to collect demographic and diagnostic data at enrollment. Longitudinal follow-up will be performed at least annually.\n\nThe CCPS includes the establishment of a biorepository, with a hub and spoke structure, with a central repository at Emory University/Children's Healthcare of Atlanta for prospective collection of some tissues, linked to local biorepositories at participating institutions. Information about inventory of tumor specimens already banked locally will be available in the database, along with reference to existing genomic studies of the tumor, such that investigators may identify and request such tissue or data for specific studies, subject to approval of the CCPS Scientific Committee."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The Primary Subjects of this study are children (age 0-21) with a CPS. Members of their Primary Family Unit will also be recruited for this study, including CPS-Affected Parents, Unaffected Parents and Siblings. Other adult family members (with documented or obligate CPS) are also eligible to enroll as Affected Family Members.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPrimary Subjects must meet all of the below criteria to be eligible for enrollment:\n\n1. Be less than 21 years of age at the time of enrollment\n2. Have a diagnosis of a specific CPS, whether they have had cancer or not\n\n * Based on clinical laboratory testing demonstrating a Pathogenic or Likely Pathogenic germline variant and/or\n * Based on well-established clinical diagnostic criteria and/or\n * Based on high clinical suspicion of a specific CPS with clinical laboratory testing demonstrating a variant of uncertain significance (VUS)\n\nAffected Parents must meet all of the following criteria to be eligible for enrollment:\n\n1. Be the biologic parent of a Primary Subject and\n2. Carry a diagnosis (or obligate diagnosis) of the familial CPS\n\nAdult Affected Siblings must meet all of the following criteria to be eligible for enrollment:\n\n1. Be the biologic sibling of a Primary Subject and\n2. Carry a diagnosis (or obligate diagnosis) of the familial CPS\n\nUnaffected Parents and Siblings must meet all of the following criteria to be eligible for enrollment\n\n1. Be the biologic parent or sibling of a Primary Subject and\n2. Not carry a diagnosis (or obligate diagnosis) of the familial CPS\n\nAffected Family Members must meet all of the following criteria to be eligible for enrollment:\n\n1\\. Carry a diagnosis of (or obligate diagnosis of) the familial CPS. Documentation is requested but not required.\n\nMore than one child from a Primary Family Unit may be a Primary Subject. An Unaffected Sibling may be reclassified as a Primary Subject if diagnosed with a CPS during childhood.\n\nExclusion Criteria:\n\n* Individuals with a strong personal or family history of cancer without a genetic or clinical diagnosis of a specific CPS are not eligible for enrollment.'}, 'identificationModule': {'nctId': 'NCT04511806', 'acronym': 'CCPS', 'briefTitle': 'Childhood Cancer Predisposition Study (CCPS)', 'organization': {'class': 'OTHER', 'fullName': 'Emory University'}, 'officialTitle': 'Childhood Cancer Predisposition Study (CCPS)', 'orgStudyIdInfo': {'id': 'STUDY00000109'}, 'secondaryIdInfos': [{'id': 'C3P-001', 'type': 'OTHER', 'domain': 'Consortium for Childhood Cancer Predisposition'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Primary Subjects', 'description': 'Children (age 0-21) with a cancer predisposition syndromes (CPS).', 'interventionNames': ['Other: Registry']}, {'label': 'Relatives of Children with CPS', 'description': 'Members of their Primary Family Unit will also be recruited for this study, including CPS-Affected Parents, Unaffected Parents and Siblings. Other adult family members (with documented or obligate CPS) are also eligible to enroll as Affected Family Members.', 'interventionNames': ['Other: Registry']}], 'interventions': [{'name': 'Registry', 'type': 'OTHER', 'description': 'This prospective registry and biorepository will collect clinical data and specimens for research in childhood cancer predisposition.', 'armGroupLabels': ['Primary Subjects', 'Relatives of Children with CPS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Christopher Porter, MD', 'role': 'CONTACT', 'email': 'chris.porter@emory.edu', 'phone': '404-727-4881'}], 'facility': "Children's Healthcare of Atlanta (CHOA)", 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lisa Diller, MD', 'role': 'CONTACT', 'email': 'lisa_diller@dfci.harvard.edu'}], 'facility': 'Dana Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Garrett Brodeur, MD', 'role': 'CONTACT', 'email': 'brodeur@email.chop.edu'}], 'facility': "Children's Hospital of Philadelphia", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '38105-3678', 'city': 'Memphis', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kim Nichols, MD', 'role': 'CONTACT', 'email': 'kim.nichols@stjude.org'}], 'facility': "St. Jude Children's Research Hospital", 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Surya Rednam, MD', 'role': 'CONTACT', 'email': 'sprednam@texaschildrens.org'}], 'facility': 'Baylor College of Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84113', 'city': 'Salt Lake City', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Joshua Schiffman, MD', 'role': 'CONTACT', 'email': 'joshua.schiffman@hci.utah.edu'}], 'facility': "Primary Children's Hospital", 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Anita Villani, MD', 'role': 'CONTACT', 'email': 'anita.villani@sickkids.ca'}], 'facility': 'Hospital for Sick Children', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Christopher Porter, MD', 'role': 'CONTACT', 'email': 'chris.porter@emory.edu', 'phone': '4047274881'}], 'overallOfficials': [{'name': 'Christopher Porter, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University'}, {'name': 'Anita Villani, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Hospital for Sick Children'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF', 'ANALYTIC_CODE'], 'timeFrame': 'Beginning 3 months and ending 5 years following article publication.', 'ipdSharing': 'YES', 'description': 'De-identified, individual participant data reported in publications', 'accessCriteria': '* Researchers who provide a methodologically sound proposal, to achieve the aims in the approved proposal\n* Proposals should be directed to chris.porter@emory.edu. Requests will be reviewed by the study committee. Access to data will require a data access agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emory University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Christopher Porter', 'investigatorAffiliation': 'Emory University'}}}}