NCT04511806

Childhood Cancer Predisposition Study (CCPS)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,050 (estimated)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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).

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 plan to: 1. Establish and maintain a framework for recruitment, participation, and surveillance of children with cancer predisposition syndromes (CPS) in clinical and translational research studies; 2. Define the natural history of disease in children with CPS; and 3. Evaluate the clinical impact and effectiveness of standard and emerging tumor surveillance strategies. The 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. The 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.

Conditions

• Pediatric Cancer

Interventions

Type	Name	Description
OTHER	Registry	This prospective registry and biorepository will collect clinical data and specimens for research in childhood cancer predisposition.

Timeline

• Start date: 2021-04-22
• Primary completion: 2030-10-01
• Completion: 2030-10-01
• First posted: 2020-08-13
• Last updated: 2025-10-29

Locations

7 sites across 2 countries: United States, Canada