Status:
RECRUITING
Childhood Cancer Predisposition Study (CCPS)
Lead Sponsor:
Emory University
Conditions:
Pediatric Cancer
Eligibility:
All Genders
Brief Summary
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 predispos...
Detailed Description
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 p...
Eligibility Criteria
Inclusion
- Primary Subjects must meet all of the below criteria to be eligible for enrollment:
- Be less than 21 years of age at the time of enrollment
- 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:
- Be the biologic parent of a Primary Subject and
- 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:
- Be the biologic sibling of a Primary Subject and
- 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
- Be the biologic parent or sibling of a Primary Subject and
- 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
- 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.
Key Trial Info
Start Date :
April 22 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2030
Estimated Enrollment :
1050 Patients enrolled
Trial Details
Trial ID
NCT04511806
Start Date
April 22 2021
End Date
October 1 2030
Last Update
October 29 2025
Active Locations (7)
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1
Children's Healthcare of Atlanta (CHOA)
Atlanta, Georgia, United States, 30322
2
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
3
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
4
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105-3678