Study on childhood cancer predisposition

Childhood Cancer Predisposition Study (CCPS)

This study is trying to learn more about children who have a higher risk of cancer and their families to improve how we monitor and care for them.

Quick facts

• Study type: Observational
• Enrollment: 1050 (estimated)
• Sex: All
• Sponsor: Emory University (Academic / other)
• Locations: 7 sites (Atlanta, Georgia and 6 other locations)
• Trial ID: NCT04511806 on ClinicalTrials.gov

What this trial studies

The Childhood Cancer Predisposition Study (CCPS) is a multi-center, longitudinal, observational study aimed at collecting clinical and biological data from children with cancer predisposition syndromes (CPS) and their relatives. The study seeks to establish a framework for recruitment and surveillance of these high-risk individuals, define the natural history of disease, and evaluate the effectiveness of tumor surveillance strategies. Approximately 350 children and 700 relatives will be enrolled annually, with longitudinal follow-up and the establishment of a biorepository for tissue specimens. This research aims to enhance understanding of cancer development and improve care for pediatric patients.

Who should consider this trial

Good fit: Ideal candidates include children under 21 with a diagnosis of a specific cancer predisposition syndrome.

Not a fit: Patients without a diagnosed cancer predisposition syndrome or those over 21 years of age will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved early detection and prevention strategies for pediatric cancer.

How similar studies have performed: Other studies focusing on cancer predisposition have shown promise, indicating potential for success in this approach.

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.

Where this trial is running

Atlanta, Georgia and 6 other locations

• Children's Healthcare of Atlanta (CHOA) — Atlanta, Georgia, United States (Recruiting)
• Dana Farber Cancer Institute — Boston, Massachusetts, United States (Recruiting)
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (Recruiting)
• St. Jude Children's Research Hospital — Memphis, Tennessee, United States (Recruiting)
• Baylor College of Medicine — Houston, Texas, United States (Recruiting)
• Primary Children's Hospital — Salt Lake City, Utah, United States (Recruiting)
• Hospital for Sick Children — Toronto, Ontario, Canada (Recruiting)

Study contacts

• Principal investigator: Christopher Porter, MD — Emory University
• Study coordinator: Christopher Porter, MD

Conditions Pediatric Cancer; Cancer predisposition