Study on childhood cancer predisposition

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Principal investigator: Christopher Porter, MD — Emory University
• Study coordinator: Christopher Porter, MD
• Email: chris.porter@emory.edu
• Phone: 4047274881

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.