- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Intervention / Treatment
Detailed Description
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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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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, United States, 90801
- Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
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Connecticut
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Farmington, Connecticut, United States, 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, United States, 33901
- Lee Cancer Care of Lee Memorial Health System
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Gainesville, Florida, United States, 32610-0232
- University of Florida Shands Cancer Center
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Hawaii
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Honolulu, Hawaii, United States, 95813
- Cancer Research Center of Hawaii
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Illinois
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Park Ridge, Illinois, United States, 60068-1174
- Advocate Lutheran General Cancer Care Center
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Michigan
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Lansing, Michigan, United States, 48910
- Breslin Cancer Center at Ingham Regional Medical Center
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Minnesota
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Minneapolis, Minnesota, United States, 55404
- Children's Hospitals and Clinics of Minneapolis
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New Hampshire
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Lebanon, New Hampshire, United States, 03756-0002
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
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New Jersey
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Hackensack, New Jersey, United States, 07601
- Hackensack University Medical Center Cancer Center
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New York
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Albany, New York, United States, 12208-3419
- Albany Medical Center Hospital
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New York, New York, United States, 10016
- NYU Cancer Institute at New York University Medical Center
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North Carolina
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Asheville, North Carolina, United States, 28801
- Mission Hospitals - Memorial Campus
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Ohio
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Dayton, Ohio, United States, 45404-1815
- Children's Medical Center - Dayton
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Youngstown, Ohio, United States, 44501
- Tod Children's Hospital - Forum Health
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19134-1095
- St. Christopher's Hospital for Children
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Tennessee
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Knoxville, Tennessee, United States, 37916
- East Tennessee Children's Hospital
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Texas
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Corpus Christi, Texas, United States, 78466
- Driscoll Children's Hospital
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Vermont
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Burlington, Vermont, United States, 05405
- Fletcher Allen Health Care - University Health Center Campus
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
- Child (< 21 years of age) with newly diagnosed cancer
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- Not specified
Study Plan
How is the study designed?
Design Details
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 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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Experimental: 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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Experimental: 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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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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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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Julie A. Ross, PhD, Masonic Cancer Center, University of Minnesota
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- AADM01P1
- COG-AADM01P1 (Other Identifier: Children's Oncology Group)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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