Childhood Cancer Predisposition Study (CCPS) (CCPS)
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).
Studieoversigt
Detaljeret beskrivelse
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:
- Establish and maintain a framework for recruitment, participation, and surveillance of children with cancer predisposition syndromes (CPS) in clinical and translational research studies;
- Define the natural history of disease in children with CPS; and
- 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.
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Christopher Porter, MD
- Telefonnummer: 4047274881
- E-mail: chris.porter@emory.edu
Studiesteder
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Ontario
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Toronto, Ontario, Canada
- Rekruttering
- Hospital for Sick Children
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Kontakt:
- Anita Villani, MD
- E-mail: anita.villani@sickkids.ca
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Georgia
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Atlanta, Georgia, Forenede Stater, 30322
- Rekruttering
- Children's Healthcare of Atlanta (CHOA)
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Kontakt:
- Christopher Porter, MD
- Telefonnummer: 404-727-4881
- E-mail: chris.porter@emory.edu
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02215
- Rekruttering
- Dana Farber Cancer Institute
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Kontakt:
- Lisa Diller, MD
- E-mail: lisa_diller@dfci.harvard.edu
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Pennsylvania
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Philadelphia, Pennsylvania, Forenede Stater, 19104
- Rekruttering
- Children's Hospital of Philadelphia
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Kontakt:
- Suzanne MacFarland, MD
- E-mail: macfarlands@chop.edu
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Tennessee
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Memphis, Tennessee, Forenede Stater, 38105-3678
- Rekruttering
- St. Jude Children's Research Hospital
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Kontakt:
- Kim Nichols, MD
- E-mail: kim.nichols@stjude.org
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Texas
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Houston, Texas, Forenede Stater, 77030
- Rekruttering
- Baylor College of Medicine
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Kontakt:
- Surya Rednam, MD
- E-mail: sprednam@texaschildrens.org
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Utah
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Salt Lake City, Utah, Forenede Stater, 84113
- Rekruttering
- Primary Children's Hospital
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Kontakt:
- Luke Maese, MD
- E-mail: luke.maese@hsci.utah.edu
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
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.
Beskrivelse
Inclusion Criteria:
Primary Subjects must meet all of the below criteria to be eligible for enrollment:
-
Be less than 21 years of age at the time of enrollment
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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:
- Be the biologic parent of a Primary Subject and
- 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:
- Be the biologic sibling of a Primary Subject and
- 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
- Be the biologic parent or sibling of a Primary Subject and
- 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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Primary Subjects
Children (age 0-21) with a cancer predisposition syndromes (CPS). |
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. |
This prospective registry and biorepository will collect clinical data and specimens for research in childhood cancer predisposition. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Establish and maintain a framework for recruitment, participation, and surveillance of children with cancer predisposition syndromes (CPS) in clinical and translational research studies.
Tidsramme: 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). |
Up to 10 years
|
|
Define the natural history of disease in children with CPS.
Tidsramme: Up to 10 years
|
To define the natural history of disease in children with CPS. |
Up to 10 years
|
|
Evaluate the clinical impact and effectiveness of standard and emerging tumor surveillance strategies.
Tidsramme: 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). |
Up to 10 years
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Christopher Porter, MD, Emory University
- Ledende efterforsker: Anita Villani, MD, The Hospital for Sick Children
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Neoplasmer
- Organisation og administration
- Sundhedstjenester Administration
- Sundhedsvæsenets kvalitet, adgang og evaluering
- Undersøgelsesteknikker
- Epidemiologiske metoder
- Dataindsamling
- Evalueringsmekanismer til sundhedsvæsenet
- Sundhedskvalitet
- Folkesundhed
- Miljø og folkesundhed
- Poster
- Registreringer
Andre undersøgelses-id-numre
- STUDY00000109
- C3P-001 (Anden identifikator: Consortium for Childhood Cancer Predisposition)
- 2020P002450 (Anden identifikator: Emory IRB)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
De-identified, individual participant data reported in publications
IPD-delingstidsramme
Beginning 3 months and ending 5 years following article publication.
IPD-delingsadgangskriterier
- 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.
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- ICF
- ANALYTIC_CODE
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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