Pediatric Cancer Clinical Trial
— CCPSOfficial title:
Childhood Cancer Predisposition Study (CCPS)
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. The 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).
Status | Recruiting |
Enrollment | 1050 |
Est. completion date | October 2030 |
Est. primary completion date | October 2030 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: Primary Subjects must meet all of the below criteria to be eligible for enrollment: 1. Be less than 21 years of age at the time of enrollment 2. Have a diagnosis of a specific CPS, whether they have had cancer or not - Based on clinical laboratory testing demonstrating a Pathogenic or Likely Pathogenic germline variant and/or - Based on well-established clinical diagnostic criteria and/or - Based on high clinical suspicion of a specific CPS with clinical laboratory testing demonstrating a variant of uncertain significance (VUS) Affected Parents must meet all of the following criteria to be eligible for enrollment: 1. Be the biologic parent of a Primary Subject and 2. Carry a diagnosis (or obligate diagnosis) of the familial CPS Adult Affected Siblings must meet all of the following criteria to be eligible for enrollment: 1. Be the biologic sibling of a Primary Subject and 2. Carry a diagnosis (or obligate diagnosis) of the familial CPS Unaffected Parents and Siblings must meet all of the following criteria to be eligible for enrollment 1. Be the biologic parent or sibling of a Primary Subject and 2. Not carry a diagnosis (or obligate diagnosis) of the familial CPS Affected Family Members must meet all of the following criteria to be eligible for enrollment: 1. Carry a diagnosis of (or obligate diagnosis of) the familial CPS. Documentation is requested but not required. More 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Canada | Hospital for Sick Children | Toronto | Ontario |
United States | Children's Healthcare of Atlanta (CHOA) | Atlanta | Georgia |
United States | Dana Farber Cancer Institute | Boston | Massachusetts |
United States | Baylor College of Medicine | Houston | Texas |
United States | St. Jude Children's Research Hospital | Memphis | Tennessee |
United States | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania |
United States | Primary Children's Hospital | Salt Lake City | Utah |
Lead Sponsor | Collaborator |
---|---|
Emory University |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Establish and maintain a framework for recruitment, participation, and surveillance of children with cancer predisposition syndromes (CPS) in clinical and translational research studies. | 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). | Up to 10 years | |
Primary | Define the natural history of disease in children with CPS. | To define the natural history of disease in children with CPS. | Up to 10 years | |
Primary | Evaluate the clinical impact and effectiveness of standard and emerging tumor surveillance strategies. | 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). | Up to 10 years |
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