- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT00433394
Registration and Informed Consent Study for the Childhood Cancer Research Network
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.
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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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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California
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Long Beach, California, Verenigde Staten, 90801
- Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
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Connecticut
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Farmington, Connecticut, Verenigde Staten, 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, Verenigde Staten, 33901
- Lee Cancer Care of Lee Memorial Health System
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Gainesville, Florida, Verenigde Staten, 32610-0232
- University of Florida Shands Cancer Center
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Hawaii
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Honolulu, Hawaii, Verenigde Staten, 95813
- Cancer Research Center of Hawaii
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Illinois
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Park Ridge, Illinois, Verenigde Staten, 60068-1174
- Advocate Lutheran General Cancer Care Center
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Michigan
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Lansing, Michigan, Verenigde Staten, 48910
- Breslin Cancer Center at Ingham Regional Medical Center
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Minnesota
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Minneapolis, Minnesota, Verenigde Staten, 55404
- Children's Hospitals and Clinics of Minneapolis
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New Hampshire
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Lebanon, New Hampshire, Verenigde Staten, 03756-0002
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
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New Jersey
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Hackensack, New Jersey, Verenigde Staten, 07601
- Hackensack University Medical Center Cancer Center
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New York
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Albany, New York, Verenigde Staten, 12208-3419
- Albany Medical Center Hospital
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New York, New York, Verenigde Staten, 10016
- NYU Cancer Institute at New York University Medical Center
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North Carolina
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Asheville, North Carolina, Verenigde Staten, 28801
- Mission Hospitals - Memorial Campus
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Ohio
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Dayton, Ohio, Verenigde Staten, 45404-1815
- Children's Medical Center - Dayton
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Youngstown, Ohio, Verenigde Staten, 44501
- Tod Children's Hospital - Forum Health
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Pennsylvania
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Philadelphia, Pennsylvania, Verenigde Staten, 19134-1095
- St. Christopher's Hospital for Children
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Tennessee
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Knoxville, Tennessee, Verenigde Staten, 37916
- East Tennessee Children's Hospital
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Texas
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Corpus Christi, Texas, Verenigde Staten, 78466
- Driscoll Children's Hospital
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Vermont
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Burlington, Vermont, Verenigde Staten, 05405
- Fletcher Allen Health Care - University Health Center Campus
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
DISEASE CHARACTERISTICS:
- Child (< 21 years of age) with newly diagnosed cancer
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- Not specified
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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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Experimenteel: 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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Experimenteel: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
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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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Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Studie stoel: Julie A. Ross, PhD, Masonic Cancer Center, University of Minnesota
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- AADM01P1
- COG-AADM01P1 (Andere identificatie: Children's Oncology Group)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .