Predisposisjonsstudie for barnekreft (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).
Studieoversikt
Detaljert 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.
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Christopher Porter, MD
- Telefonnummer: 4047274881
- E-post: 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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Ta kontakt med:
- Anita Villani, MD
- E-post: anita.villani@sickkids.ca
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Georgia
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Atlanta, Georgia, Forente stater, 30322
- Rekruttering
- Children's Healthcare of Atlanta (CHOA)
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Ta kontakt med:
- Christopher Porter, MD
- Telefonnummer: 404-727-4881
- E-post: chris.porter@emory.edu
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Massachusetts
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Boston, Massachusetts, Forente stater, 02215
- Rekruttering
- Dana Farber Cancer Institute
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Ta kontakt med:
- Lisa Diller, MD
- E-post: lisa_diller@dfci.harvard.edu
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Pennsylvania
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Philadelphia, Pennsylvania, Forente stater, 19104
- Rekruttering
- Children's Hospital of Philadelphia
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Ta kontakt med:
- Suzanne MacFarland, MD
- E-post: macfarlands@chop.edu
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Tennessee
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Memphis, Tennessee, Forente stater, 38105-3678
- Rekruttering
- St. Jude Children's Research Hospital
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Ta kontakt med:
- Kim Nichols, MD
- E-post: kim.nichols@stjude.org
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Texas
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Houston, Texas, Forente stater, 77030
- Rekruttering
- Baylor College of Medicine
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Ta kontakt med:
- Surya Rednam, MD
- E-post: sprednam@texaschildrens.org
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Utah
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Salt Lake City, Utah, Forente stater, 84113
- Rekruttering
- Primary Children's Hospital
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Ta kontakt med:
- Luke Maese, MD
- E-post: luke.maese@hsci.utah.edu
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
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 studiet utformet?
Designdetaljer
- Observasjonsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / 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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Christopher Porter, MD, Emory University
- Hovedetterforsker: Anita Villani, MD, The Hospital for Sick Children
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- STUDY00000109
- C3P-001 (Annen identifikator: Consortium for Childhood Cancer Predisposition)
- 2020P002450 (Annen identifikator: Emory IRB)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
De-identified, individual participant data reported in publications
IPD-delingstidsramme
Beginning 3 months and ending 5 years following article publication.
Tilgangskriterier for IPD-deling
- 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 Støtteinformasjonstype
- STUDY_PROTOCOL
- ICF
- ANALYTIC_CODE
Legemiddel- og utstyrsinformasjon, studiedokumenter
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