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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 : April 29, 2021
Sponsor:
Information provided by (Responsible Party):
Christopher Porter, Emory University

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).


Condition or disease Intervention/treatment
Pediatric Cancer Other: Registry

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1050 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Childhood Cancer Predisposition Study (CCPS)
Actual Study Start Date : April 22, 2021
Estimated Primary Completion Date : October 2030
Estimated Study Completion Date : October 2030

Group/Cohort Intervention/treatment
Primary Subjects
Children (age 0-21) with a cancer predisposition syndromes (CPS).
Other: Registry
This prospective registry and biorepository will collect clinical data and specimens for research in childhood cancer predisposition.

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




Primary Outcome Measures :
  1. 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).

  2. 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.

  3. 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).


Biospecimen Retention:   Samples With DNA

From the Primary Subjects:

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

From Parents and siblings

- Germline DNA (required).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04511806


Contacts
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Contact: Christopher Porter, MD 4047274881 chris.porter@emory.edu

Locations
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United States, Georgia
Children's Healthcare of Atlanta (CHOA) Recruiting
Atlanta, Georgia, United States, 30322
Contact: Christopher Porter, MD    404-727-4881    chris.porter@emory.edu   
United States, Massachusetts
Dana Farber Cancer Institute Not yet recruiting
Boston, Massachusetts, United States, 02215
Contact: Lisa Diller, MD       lisa_diller@dfci.harvard.edu   
United States, Pennsylvania
Children's Hospital of Philadelphia Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Garrett Brodeur, MD       brodeur@email.chop.edu   
United States, Tennessee
St. Jude Children's Research Hospital Not yet recruiting
Memphis, Tennessee, United States, 38105-3678
Contact: Kim Nichols, MD       kim.nichols@stjude.org   
United States, Texas
Baylor College of Medicine Not yet recruiting
Houston, Texas, United States, 77030
Contact: Surya Rednam, MD       sprednam@texaschildrens.org   
United States, Utah
Primary Children's Hospital Not yet recruiting
Salt Lake City, Utah, United States, 84113
Contact: Joshua Schiffman, MD       joshua.schiffman@hci.utah.edu   
Canada, Ontario
Hospital for Sick Children Not yet recruiting
Toronto, Ontario, Canada
Contact: Anita Villani, MD       anita.villani@sickkids.ca   
Sponsors and Collaborators
Emory University
Investigators
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Principal Investigator: Christopher Porter, MD Emory University
Principal Investigator: Anita Villani, MD The Hospital for Sick Children
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Responsible Party: Christopher Porter, Associate Professor, Emory University
ClinicalTrials.gov Identifier: NCT04511806    
Other Study ID Numbers: STUDY00000109
C3P-001 ( Other Identifier: Consortium for Childhood Cancer Predisposition )
First Posted: August 13, 2020    Key Record Dates
Last Update Posted: April 29, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified, individual participant data reported in publications
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Christopher Porter, Emory University:
Cancer predisposition
Additional relevant MeSH terms:
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Disease Susceptibility
Disease Attributes
Pathologic Processes