Recruiting

Observational Study

Sponsor:

Emory University

Code:

NCT04511806

Conditions

Pediatric Cancer

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Registry

Study Details

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

Study ID

NCT04511806

Start date

Apr 22, 2021

Status verified date

Oct, 2025

Completion date

Oct, 2030

Anticipated

Primary completion date

Oct, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

1050 participants

Anticipated

Interventions and Outcome Measures

Arms

Primary Subjects

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

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.

Interventions

Registry

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

Primary outcome measure

  • Establish and maintain a framework for recruitment, participation, and surveillance of children with cancer predisposition syndromes (CPS) in clinical and translational research studies. [ Time Frame: Up to 10 years ]
  • Define the natural history of disease in children with CPS. [ Time Frame: Up to 10 years ]
  • Evaluate the clinical impact and effectiveness of standard and emerging tumor surveillance strategies. [ Time Frame: Up to 10 years ]

Central Contacts and Locations

Central contacts

Christopher Porter, MD

4047274881chris.porter@emory.edu

Locations

Children's Healthcare of Atlanta (CHOA)

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Garrett Brodeur, MD

brodeur@email.chop.edu

St. Jude Children's Research Hospital

Recruiting

Memphis, Tennessee, United States, 38105-3678

Contacts

Kim Nichols, MD

kim.nichols@stjude.org

Baylor College of Medicine

Recruiting

Houston, Texas, United States, 77030

Contacts

Primary Children's Hospital

Recruiting

Salt Lake City, Utah, United States, 84113

Contacts

Joshua Schiffman, MD

joshua.schiffman@hci.utah.edu

Hospital for Sick Children

Recruiting

Toronto, Ontario, Canada

Contacts

Anita Villani, MD

anita.villani@sickkids.ca

More Information

Sponsor

Emory University

Last update posted

Oct 29, 2025

Last verified

Oct, 2025

Keywords

  • Cancer predisposition

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Emory University on 2025-10-29.