Childhood Cancer Predisposition Study (CCPS)

Pediatric Cancer Clinical Trial

— CCPS  

Official title:

Childhood Cancer Predisposition Study (CCPS)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04511806
• Other study ID #: STUDY00000109
• Secondary ID: C3P-001
• Status: Recruiting
• Start date: April 22, 2021
• Est. completion date: October 2030

Study information

• Verified date: September 2023
• Source: Emory University
• Contact: Christopher Porter, MD
• Phone: 4047274881
• Email: chris.porter[@]emory.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

Description:

The CCPS is designed as a multi-center, longitudinal, observational study that will collect clinical and biological data and specimens from children with a CPS and their relatives. The investigators plan to:

1. Establish and maintain a framework for recruitment, participation, and surveillance of children with cancer predisposition syndromes (CPS) in clinical and translational research studies;

2. Define the natural history of disease in children with CPS; and

3. Evaluate the clinical impact and effectiveness of standard and emerging tumor surveillance strategies.

The study will enroll approximately 350 Children and 700 Relatives per year. The investigators plan to collect demographic and diagnostic data at enrollment. Longitudinal follow-up will be performed at least annually.

The CCPS includes the establishment of a biorepository, with a hub and spoke structure, with a central repository at Emory University/Children's Healthcare of Atlanta for prospective collection of some tissues, linked to local biorepositories at participating institutions. Information about inventory of tumor specimens already banked locally will be available in the database, along with reference to existing genomic studies of the tumor, such that investigators may identify and request such tissue or data for specific studies, subject to approval of the CCPS Scientific Committee.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1050
• Est. completion date: October 2030
• Est. primary completion date: October 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Disease Susceptibility
• Pediatric Cancer

Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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