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COG Registry - Childhood Cancer Research Network (CCRN)
This study is currently recruiting participants.
Verified by M.D. Anderson Cancer Center, November 2008
Sponsored by: M.D. Anderson Cancer Center
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00799253
  Purpose

Objectives:

  1. To obtain informed consent from parents of infants, children, adolescents, and young adults newly diagnosed with cancer (and their child when appropriate) to enter their names and certain information concerning their child, including: their name, postal/zip code, social security number (SSN), date of birth, diagnosis, diagnosis date, institution, race, ethnicity, and sex into the Childhood Cancer Research Network. This is referred to as: Entry in the CCRN with consent but without permission for future contact.

    1.1 {For children under the age of majority at the time of parental consent:} Once the child reaches the age of majority, to obtain informed consent from that child to allow her/his name and other identifying information to continue to be available to the Childhood Cancer Research Network.

  2. To obtain informed consent from parents of infants, children, adolescents, and young adults newly diagnosed with cancer (and the child when appropriate) for permission to be possibly contacted in the future to consider participating in non-therapeutic and prevention research studies involving the parents and/or the child. This consent includes the information collected in 1.1 (must include parent's and child's name) along with current address and telephone number. This is referred to as: Entry in the CCRN with consent including permission for future contact.

    • 2.1. {For children under the age of majority at the time of parental consent for future contact:} Once the child reaches the age of majority, to obtain informed consent for permission to be possibly contacted in the future to consider participating in non-therapeutic and prevention research studies. This consent includes the information collected in 1.1.2 (must include name) along with current address and telephone number.

Condition
Pediatric Cancers

MedlinePlus related topics: Cancer
U.S. FDA Resources
Study Type: Observational
Study Design: Case-Only, Prospective
Official Title: Protocol for the Enrollment on the Official COG Registry, The Childhood Cancer Research Network (CCRN)

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • The goal of this registry research study is to collect clinical information about every child and young adult diagnosed with cancer in the United States and Canada. [ Time Frame: 50 Years ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 9999
Study Start Date: August 2008
Estimated Primary Completion Date: August 2058 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Enrollment in Children's Oncology Group (COG) Registry, The Childhood Cancer Research Network (CCRN) for individuals diagnosed with one of the pediatric cancers.

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

New patients seen in Children's Oncology Group (COG) member institutions which include more than 200 hospitals that together treat most children diagnosed with cancer in the United States and Canada.

Criteria

Inclusion Criteria:

  1. All new patients seen in COG member institutions with any of the following diagnoses are eligible: All cancer cases with an ICD-O histologic behavior code of two "2" (carcinoma in situ) or three "3" (malignant);
  2. All new patients seen in COG member institutions with any of the following diagnoses are eligible: All lesions of the central nervous system regardless of behavior, i.e., benign, borderline or malignant;
  3. All new patients seen in COG member institutions with any of the following diagnoses are eligible: The benign/borderline conditions which will be reportable by agreement shall include: Mesoblastic nephroma, All teratomas, regardless of locations, Theca cell- granulosa cell tumor, Lymphoproliferative disease, Ganglioneuroma, Myeloproliferative disease, Langerhan's Cell histiocytosis
  4. Approval for the use of this protocol by the local Institutional Review Board or equivalent must be obtained, in accordance with institutional assurance policies of the U.S. Department of Health and Human Services and the Canadian Tri-Council Report of the Medical Research Council of Canada.
  5. All patients and/or their parents or legal guardians must sign a written informed consent.
  6. PHI Authorization:The local institution must provide verification that authorization to release PHI was obtained. With this authorization a unique patient number (UPN) will be assigned, which will be used as the COG patient ID number.

Exclusion Criteria:

1) Any patient who refuses a written informed consent.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00799253

Contacts
Contact: Joann L. Ater, MD, BA 713-792-6620

Locations
United States, Texas
UT MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Joan Ater, MD, BA     713-792-6620        
Principal Investigator: Joan Ater, MD, BA            
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Joan Ater, MD, BA UT MD Anderson Cancer Center
  More Information

UT MD Anderson Cancer Center website  This link exits the ClinicalTrials.gov site

Responsible Party: UT MD Anderson Cancer Center ( Joann L. Ater, MD/Professor )
Study ID Numbers: COGACCRN07
Study First Received: November 25, 2008
Last Updated: November 25, 2008
ClinicalTrials.gov Identifier: NCT00799253  
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Pediatric Cancers
Pediatrics
COG
Children's Oncology Group
COG Registry
Childhood Cancer Research Network
CCRN

ClinicalTrials.gov processed this record on January 16, 2009