RecruitingNCT04511806

Childhood Cancer Predisposition Study (CCPS)

Sponsor

Emory University

Enrollment

1,050 participants

Start Date

Apr 22, 2021

Study Type

OBSERVATIONAL

Conditions

Pediatric Cancer

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 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).

Eligibility

Inclusion Criteria18

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:
\. 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 Criteria1

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.

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