Registration and Informed Consent Study for the Childhood Cancer Research Network
26. juni 2013 oppdatert av: Children's Oncology Group
Protocol for Registration and Consent to the Childhood Cancer Research Network - A Limited Institution Pilot
RATIONALE: Collecting informed consent from parents of children with cancer to register with the Childhood Cancer Research Network may help the study of cancer in the future.
PURPOSE: This study is collecting informed consent to register younger patients with cancer into the Childhood Cancer Research Network.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Detaljert beskrivelse
OBJECTIVES:
- Obtain informed consent from parents (and the child, when appropriate) of children diagnosed with cancer (who are under 21 years of age) to register their child's name and address with the Childhood Cancer Research Network.
- Obtain informed consent from parents (and the child, when appropriate) of children diagnosed with cancer (who are under 21 years of age) to be contacted in the future for possible participation in non-therapeutic research studies involving the parents and/or child.
- Facilitate the systematic registration of pediatric and adolescent patients diagnosed with cancer into the Childhood Cancer Research Network.
OUTLINE: Consent is obtained from parents (and pediatric patients, where applicable) to register the patient's and parent's names and addresses with the Childhood Cancer Research Network, provide a copy of the pathology report to the Network, and contact parents in the future for possible non-therapeutic research studies involving the parents and/or child.
Information provided will be held in strict confidence.
PROJECTED ACCRUAL: Not specified
Studietype
Intervensjonell
Registrering (Faktiske)
2242
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Alberta
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Edmonton, Alberta, Canada, T6G 1Z2
- University of Alberta Hospital
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Quebec
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Montreal, Quebec, Canada, H3H 1P3
- Montreal Children's Hospital at McGill University Health Center
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-
-
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California
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Long Beach, California, Forente stater, 90801
- Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
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Connecticut
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Farmington, Connecticut, Forente stater, 06360-2875
- Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
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Florida
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Fort Myers, Florida, Forente stater, 33901
- Lee Cancer Care of Lee Memorial Health System
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Gainesville, Florida, Forente stater, 32610-0232
- University of Florida Shands Cancer Center
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Hawaii
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Honolulu, Hawaii, Forente stater, 95813
- Cancer Research Center of Hawaii
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Illinois
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Park Ridge, Illinois, Forente stater, 60068-1174
- Advocate Lutheran General Cancer Care Center
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Michigan
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Lansing, Michigan, Forente stater, 48910
- Breslin Cancer Center at Ingham Regional Medical Center
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Minnesota
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Minneapolis, Minnesota, Forente stater, 55404
- Children's Hospitals and Clinics of Minneapolis
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New Hampshire
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Lebanon, New Hampshire, Forente stater, 03756-0002
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
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New Jersey
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Hackensack, New Jersey, Forente stater, 07601
- Hackensack University Medical Center Cancer Center
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New York
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Albany, New York, Forente stater, 12208-3419
- Albany Medical Center Hospital
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New York, New York, Forente stater, 10016
- NYU Cancer Institute at New York University Medical Center
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North Carolina
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Asheville, North Carolina, Forente stater, 28801
- Mission Hospitals - Memorial Campus
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Ohio
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Dayton, Ohio, Forente stater, 45404-1815
- Children's Medical Center - Dayton
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Youngstown, Ohio, Forente stater, 44501
- Tod Children's Hospital - Forum Health
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Pennsylvania
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Philadelphia, Pennsylvania, Forente stater, 19134-1095
- St. Christopher's Hospital for Children
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Tennessee
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Knoxville, Tennessee, Forente stater, 37916
- East Tennessee Children's Hospital
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Texas
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Corpus Christi, Texas, Forente stater, 78466
- Driscoll Children's Hospital
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Vermont
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Burlington, Vermont, Forente stater, 05405
- Fletcher Allen Health Care - University Health Center Campus
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Ikke eldre enn 20 år (Barn, Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
DISEASE CHARACTERISTICS:
- Child (< 21 years of age) with newly diagnosed cancer
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- Not specified
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Stratum 1: No Consent for personal identification
Data to be collected for this stratum include histology, primary site, treating hospital, and institutional principal investigator.
Data will be coded using the North American Association for Central Cancer Registries (N.A.A.C.C.R.) data standards for cancer registries.
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Eksperimentell: Stratum 2: Consent for personal identification - No Contact
Data will be collected for this study include:child's name, parent's name, address, telephone number, child's date of birth, race, ethnicity, histology, primary site, treating hospital, and institutional principal investigator.
Data will be coded using the North American Association for Central Cancer Registries (N.A.A.C.C.R.) data standards for cancer registries.
No contact for future to ask me to consider taking part in Research Network approved studies
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|
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Eksperimentell: Stratum 3: Consent for personal identification - Contact
Data will be collected for this study include:child's name, parent's name, address, telephone number, child's date of birth, race, ethnicity, histology, primary site, treating hospital, and institutional principal investigator.
Data will be coded using the North American Association for Central Cancer Registries (N.A.A.C.C.R.) data standards for cancer registries Someone from the Childhood Cancer Research Network may contact me in the future to ask me to consider taking part in Research Network approved studies
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Hva måler studien?
Primære resultatmål
Resultatmål |
|---|
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Informed consent collection to register with the Childhood Cancer Research Network
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Informed consent collection for possible participation in future non-therapeutic research studies
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Facilitation of systematic registration into the Childhood Cancer Research Network
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Studiestol: Julie A. Ross, PhD, Masonic Cancer Center, University of Minnesota
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. mai 2001
Primær fullføring (Faktiske)
1. januar 2007
Studiet fullført (Faktiske)
1. januar 2011
Datoer for studieregistrering
Først innsendt
9. februar 2007
Først innsendt som oppfylte QC-kriteriene
9. februar 2007
Først lagt ut (Anslag)
12. februar 2007
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
27. juni 2013
Siste oppdatering sendt inn som oppfylte QC-kriteriene
26. juni 2013
Sist bekreftet
1. juni 2013
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- AADM01P1
- COG-AADM01P1 (Annen identifikator: Children's Oncology Group)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .