Registration and Informed Consent Study for the Childhood Cancer Research Network

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00433394
First received: February 9, 2007
Last updated: June 26, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Unspecified Childhood Solid Tumor, Protocol Specific
Procedure: cancer prevention intervention
Procedure: educational intervention

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Protocol for Registration and Consent to the Childhood Cancer Research Network - A Limited Institution Pilot

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • 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

Enrollment: 2242
Study Start Date: May 2001
Study Completion Date: January 2011
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Procedure: educational intervention
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
Procedure: cancer prevention intervention Procedure: educational intervention
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
Procedure: cancer prevention intervention Procedure: educational intervention

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

  Eligibility

Ages Eligible for Study:   up to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

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

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00433394

  Show 21 Study Locations
Sponsors and Collaborators
Children's Oncology Group
Investigators
Study Chair: Julie A. Ross, PhD University of Minnesota - Clinical and Translational Science Institute
  More Information

No publications provided

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00433394     History of Changes
Obsolete Identifiers: NCT00228709
Other Study ID Numbers: AADM01P1, COG-AADM01P1
Study First Received: February 9, 2007
Last Updated: June 26, 2013
Health Authority: United States: Federal Government

Keywords provided by Children's Oncology Group:
unspecified childhood solid tumor, protocol specific

ClinicalTrials.gov processed this record on September 16, 2014