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Childhood Cancer Predisposition Study (CCPS) (CCPS)

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ClinicalTrials.gov Identifier: NCT04511806
Recruitment Status : Recruiting
First Posted : August 13, 2020
Last Update Posted : August 24, 2022
Sponsor:
Information provided by (Responsible Party):
Christopher Porter, Emory University

Tracking Information
First Submitted Date August 11, 2020
First Posted Date August 13, 2020
Last Update Posted Date August 24, 2022
Actual Study Start Date April 22, 2021
Estimated Primary Completion Date October 2030   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 11, 2020)
  • 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 ]
    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).
  • Define the natural history of disease in children with CPS. [ Time Frame: Up to 10 years ]
    To define the natural history of disease in children with CPS.
  • Evaluate the clinical impact and effectiveness of standard and emerging tumor surveillance strategies. [ Time Frame: Up to 10 years ]
    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).
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Childhood Cancer Predisposition Study (CCPS)
Official Title Childhood Cancer Predisposition Study (CCPS)
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).

Detailed 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.

Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 10 Years
Biospecimen Retention:   Samples With DNA
Description:

From the Primary Subjects:

- Germline DNA (required), serial blood and stool samples (optional)

From Parents and siblings

- Germline DNA (required).

Sampling Method Non-Probability Sample
Study Population The Primary Subjects of this study are children (age 0-21) with a 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.
Condition Pediatric Cancer
Intervention Other: Registry
This prospective registry and biorepository will collect clinical data and specimens for research in childhood cancer predisposition.
Study Groups/Cohorts
  • Primary Subjects
    Children (age 0-21) with a cancer predisposition syndromes (CPS).
    Intervention: Other: Registry
  • 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.
    Intervention: Other: Registry
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 11, 2020)
1050
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 2030
Estimated Primary Completion Date October 2030   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Christopher Porter, MD 4047274881 chris.porter@emory.edu
Listed Location Countries Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04511806
Other Study ID Numbers STUDY00000109
C3P-001 ( Other Identifier: Consortium for Childhood Cancer Predisposition )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: De-identified, individual participant data reported in publications
Supporting Materials: Study Protocol
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Analytic Code
Time Frame: Beginning 3 months and ending 5 years following article publication.
Access Criteria:
  • Researchers who provide a methodologically sound proposal, to achieve the aims in the approved proposal
  • Proposals should be directed to chris.porter@emory.edu. Requests will be reviewed by the study committee. Access to data will require a data access agreement.
Current Responsible Party Christopher Porter, Emory University
Original Responsible Party Same as current
Current Study Sponsor Emory University
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Christopher Porter, MD Emory University
Principal Investigator: Anita Villani, MD The Hospital for Sick Children
PRS Account Emory University
Verification Date August 2022