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Registration and Informed Consent Study for the Childhood Cancer Research Network

26. juni 2013 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

2242

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • University of Alberta Hospital
    • Quebec
      • Montreal, Quebec, Canada, H3H 1P3
        • Montreal Children's Hospital at McGill University Health Center
  • Forenede Stater
    • California
      • Long Beach, California, Forenede Stater, 90801
        • Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
    • Connecticut
      • Farmington, Connecticut, Forenede Stater, 06360-2875
        • Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
    • Florida
      • Fort Myers, Florida, Forenede Stater, 33901
        • Lee Cancer Care of Lee Memorial Health System
      • Gainesville, Florida, Forenede Stater, 32610-0232
        • University of Florida Shands Cancer Center
    • Hawaii
      • Honolulu, Hawaii, Forenede Stater, 95813
        • Cancer Research Center of Hawaii
    • Illinois
      • Park Ridge, Illinois, Forenede Stater, 60068-1174
        • Advocate Lutheran General Cancer Care Center
    • Michigan
      • Lansing, Michigan, Forenede Stater, 48910
        • Breslin Cancer Center at Ingham Regional Medical Center
    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater, 55404
        • Children's Hospitals and Clinics of Minneapolis
    • New Hampshire
      • Lebanon, New Hampshire, Forenede Stater, 03756-0002
        • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
    • New Jersey
      • Hackensack, New Jersey, Forenede Stater, 07601
        • Hackensack University Medical Center Cancer Center
    • New York
      • Albany, New York, Forenede Stater, 12208-3419
        • Albany Medical Center Hospital
      • New York, New York, Forenede Stater, 10016
        • NYU Cancer Institute at New York University Medical Center
    • North Carolina
      • Asheville, North Carolina, Forenede Stater, 28801
        • Mission Hospitals - Memorial Campus
    • Ohio
      • Dayton, Ohio, Forenede Stater, 45404-1815
        • Children's Medical Center - Dayton
      • Youngstown, Ohio, Forenede Stater, 44501
        • Tod Children's Hospital - Forum Health
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19134-1095
        • St. Christopher's Hospital for Children
    • Tennessee
      • Knoxville, Tennessee, Forenede Stater, 37916
        • East Tennessee Children's Hospital
    • Texas
      • Corpus Christi, Texas, Forenede Stater, 78466
        • Driscoll Children's Hospital
    • Vermont
      • Burlington, Vermont, Forenede Stater, 05405
        • Fletcher Allen Health Care - University Health Center Campus

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

Ikke ældre end 20 år (Barn, Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

DISEASE CHARACTERISTICS:

  • Child (< 21 years of age) with newly diagnosed cancer

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Procedure: educational intervention
Eksperimentel: 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
Procedure: kræftforebyggende intervention
Procedure: educational intervention
Eksperimentel: 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
Procedure: kræftforebyggende intervention
Procedure: educational intervention

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Informed consent collection to register with the Childhood Cancer Research Network
Informed consent collection for possible participation in future non-therapeutic research studies
Facilitation of systematic registration into the Childhood Cancer Research Network

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Children's Oncology Group

Samarbejdspartnere

National Cancer Institute (NCI)

Efterforskere

  • Studiestol: Julie A. Ross, PhD, Masonic Cancer Center, University of Minnesota

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. maj 2001

Primær færdiggørelse (Faktiske)

1. januar 2007

Studieafslutning (Faktiske)

1. januar 2011

Datoer for studieregistrering

Først indsendt

9. februar 2007

Først indsendt, der opfyldte QC-kriterier

9. februar 2007

Først opslået (Skøn)

12. februar 2007

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

27. juni 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. juni 2013

Sidst verificeret

1. juni 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • AADM01P1
  • COG-AADM01P1 (Anden identifikator: Children's Oncology Group)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Betingelser

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Sponsor / samarbejdspartnere

Placeringer

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