Childhood Cancer Predisposition Study (CCPS)

NCT04511806 | Recruiting

• 2 other identifiers: STUDY00000109C3P-001
• Study Type: observational
• Target: 1,050
• Locations: 2 countries
• Sites: 7

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).

Conditions

Pediatric Cancer

Keywords

Cancer predisposition

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

Primary Subjects

Children (age 0-21) with a cancer predisposition syndromes (CPS).

Other: Registry

Relatives of Children with CPS

Members of their Primary Family Unit will also be recruited for this study, including CPS-Affected Parents, Unaffected Parents and Siblings. Other adult family members (with documented or obligate CPS) are also eligible to enroll as Affected Family Members.

Other: Registry

Interventions

Registry OTHER

This prospective registry and biorepository will collect clinical data and specimens for research in childhood cancer predisposition.

Primary Subjects; Relatives of Children with CPS

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The Primary Subjects of this study are children (age 0-21) with a CPS. Members of their Primary Family Unit will also be recruited for this study, including CPS-Affected Parents, Unaffected Parents and Siblings. Other adult family members (with documented or obligate CPS) are also eligible to enroll as Affected Family Members.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Emory University: lead

Study Sites (7)

Children's Healthcare of Atlanta (CHOA)

Atlanta, Georgia, 30322, United States

RECRUITING

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105-3678, United States

RECRUITING

Baylor College of Medicine

Houston, Texas, 77030, United States

RECRUITING

Primary Children's Hospital

Salt Lake City, Utah, 84113, United States

RECRUITING

Hospital for Sick Children

Toronto, Ontario, Canada

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

From the Primary Subjects: \- Germline DNA (required), serial blood and stool samples (optional) From Parents and siblings \- Germline DNA (required).

MeSH Terms

Conditions

Neoplasms

Interventions

Registries

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Records; Organization and Administration; Health Services Administration; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Christopher Porter, MD

  Emory University

  PRINCIPAL INVESTIGATOR

• Anita Villani, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christopher Porter, MD

CONTACT

4047274881; chris.porter@emory.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 11, 2020
• First Posted: August 13, 2020
• Study Start: April 22, 2021
• Primary Completion (Estimated): October 1, 2030
• Study Completion (Estimated): October 1, 2030
• Last Updated: October 29, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Time Frame: Beginning 3 months and ending 5 years following article publication.
• Access Criteria: * Researchers who provide a methodologically sound proposal, to achieve the aims in the approved proposal * Proposals should be directed to chris.porter@emory.edu. Requests will be reviewed by the study committee. Access to data will require a data access agreement.

Locations

CA (1); US (6)