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Childhood Cancer Predisposition Study

Status
Active
Cancer Type
Cancer-Related Syndrome
Trial Phase
Eligibility
0 - 21 Years, Male and Female
Study Type
Other
NCT ID
NCT04511806
Protocol IDs
CHOA4972-20 (primary)
NCI-2020-01621
STUDY00000109
Study Sponsor
Children's Healthcare of Atlanta - Egleston

Summary

This study collects data to create a multicenter registry and biorepository. Studying individuals at high risk for childhood cancer may help doctors to understand carcinogenesis, tumor surveillance, early detection, and cancer prevention, which may collectively contribute to improving care and outcomes for pediatric patients with cancer and those with cancer predisposition syndromes.

Objectives

PRIMARY OBJECTIVES:
I. To establish and maintain a framework for recruitment, participation, and surveillance of children with cancer predisposition syndromes (CPS) in clinical and translational research studies.
II. To define the natural history of disease in children with CPS.
II. To evaluate the clinical impact and effectiveness of standard and emerging tumor surveillance strategies.

OUTLINE:
All participants undergo collection of blood, saliva, or buccal swab for germline deoxyribonucleic acid (DNA). Primary subjects also undergo collection of blood annually, leftover tumor tissue (optional), and radiologic imaging files. Primary subjects' medical data is abstracted.

Eligibility

  1. PRIMARY SUBJECTS: 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)
  2. PRIMARY SUBJECTS: Participation in other registries does not preclude participation in the childhood cancer predisposition study (CCPS). To the contrary, participation in other well-established, disease specific registries (e.g. DICER1 registry, National Cancer Institute [NCI] Li-Fraumeni Syndrome Study, Li- Fraumeni Syndrome Association [FSA] Consortium registry, etc.) is encouraged
  3. PRIMARY SUBJECTS: 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
  4. AFFECTED PARENTS: Be the biologic parent of a primary subject
  5. AFFECTED PARENTS: Carry a diagnosis (or obligate diagnosis) of the familial CPS
  6. UNAFFECTED PARENTS AND SIBLINGS: Be the biologic parent or sibling of a primary subject
  7. UNAFFECTED PARENTS AND SIBLINGS: Not carry a diagnosis (or obligate diagnosis) of the familial CPS
  8. AFFECTED FAMILY MEMBERS: Carry a diagnosis of (or obligate diagnosis of) the familial CPS. Documentation is requested but not required
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.