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History of Changes for Study: NCT04511806
Childhood Cancer Predisposition Study (CCPS) (CCPS)
Latest version (submitted August 23, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 August 11, 2020 None (earliest Version on record)
2 August 12, 2020 Study Description and Study Status
3 August 18, 2020 Contacts/Locations and Study Status
4 November 16, 2020 Study Status
5 January 8, 2021 Study Status
6 March 12, 2021 Study Status
7 April 28, 2021 Recruitment Status, Study Status and Contacts/Locations
8 April 29, 2022 Study Status
9 August 23, 2022 Study Status and Contacts/Locations
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Study NCT04511806
Submitted Date:  August 11, 2020 (v1)

Open or close this module Study Identification
Unique Protocol ID: STUDY00000109
Brief Title: Childhood Cancer Predisposition Study (CCPS) (CCPS)
Official Title: Childhood Cancer Predisposition Study (CCPS)
Secondary IDs: C3P-001 [Consortium for Childhood Cancer Predisposition]
Open or close this module Study Status
Record Verification: August 2020
Overall Status: Not yet recruiting
Study Start: October 2020
Primary Completion: October 2030 [Anticipated]
Study Completion: October 2030 [Anticipated]
First Submitted: August 11, 2020
First Submitted that
Met QC Criteria:
August 11, 2020
First Posted: August 13, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
August 11, 2020
Last Update Posted: August 13, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Emory University
Responsible Party: Principal Investigator
Investigator: Christopher Porter
Official Title: Associate Professor
Affiliation: Emory University
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
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. We 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.

Open or close this module Conditions
Conditions: Pediatric Cancer
Keywords: Cancer predisposition
Open or close this module Study Design
Study Type: Observational [Patient Registry]
Observational Study Model: Cohort
Time Perspective: Prospective
Biospecimen Retention: Samples With DNA
Biospecimen Description:

From the Primary Subjects:

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

From Parents and siblings

- Germline DNA (required).

Enrollment: 1050 [Anticipated]
Number of Groups/Cohorts 2
Target Follow-Up Duration: 10 Years
Open or close this module Groups and Interventions
Groups/Cohorts Interventions
Primary Subjects
Children (age 0-21) with a cancer predisposition syndromes (CPS).
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.
Registry
This prospective registry and biorepository will collect clinical data and specimens for research in childhood cancer predisposition.
Open or close this module Outcome Measures
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).
Open or close this module Eligibility
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.
Sampling Method: Non-Probability Sample
Minimum Age:
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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.
Open or close this module Contacts/Locations
Central Contact Person: Christopher Porter, MD
Telephone: 4047274881
Email: chris.porter@emory.edu
Study Officials: Christopher Porter, MD
Principal Investigator
Emory University
Anita Villani, MD
Principal Investigator
The Hospital for Sick Children
Locations: United States, Georgia
Children's Healthcare of Atlanta (CHOA)
Atlanta, Georgia, United States, 30322
Contact:Contact: Christopher Porter, MD 404-727-4881 chris.porter@emory.edu
Contact:Principal Investigator: Christopher Porter, MD
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Contact:Contact: Lisa Diller, MD lisa_diller@dfci.harvard.edu
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Contact:Contact: Garrett Brodeur, MD brodeur@email.chop.edu
United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105-3678
Contact:Contact: Kim Nichols, MD kim.nichols@stjude.org
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Contact:Contact: Sharon Plon, MD splon@bcm.edu
United States, Utah
Primary Children's Hospital
Salt Lake City, Utah, United States, 84113
Contact:Contact: Joshua Schiffman, MD joshua.schiffman@hci.utah.edu
Canada, Ontario
Hospital for Sick Children
Toronto, Ontario, Canada
Contact:Contact: Anita Villani, MD anita.villani@sickkids.ca
Open or close this module IPDSharing
Plan to Share IPD: Yes
De-identified, individual participant data reported in publications
Supporting Information:
Study Protocol
Informed Consent Form (ICF)
Analytic Code
Time Frame:
Beginning 3 months and ending 5 years following article publication.
Access Criteria:
URL:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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