NCT04511806 Childhood Cancer Predisposition Study (CCPS)
| NCT ID | NCT04511806 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Emory University |
| Condition | Pediatric Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,050 participants |
| Start Date | 2021-04-22 |
| Primary Completion | 2030-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,050 participants in total. It began in 2021-04-22 with a primary completion date of 2030-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 Criteria
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.
Contact & Investigator
Christopher Porter, MD
PRINCIPAL INVESTIGATOR
Emory University
Frequently Asked Questions
Who can join the NCT04511806 clinical trial?
This trial is open to participants of all sexes, studying Pediatric Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04511806 currently recruiting?
Yes, NCT04511806 is actively recruiting participants. Contact the research team at chris.porter@emory.edu for enrollment information.
Where is the NCT04511806 trial being conducted?
This trial is being conducted at Atlanta, United States, Boston, United States, Philadelphia, United States, Memphis, United States and 3 additional locations.
Who is sponsoring the NCT04511806 clinical trial?
NCT04511806 is sponsored by Emory University. The principal investigator is Christopher Porter, MD at Emory University. The trial plans to enroll 1,050 participants.
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