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Enrollment on the Childhood Cancer Research Network (CCRN) of the Children s Oncology Group

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ClinicalTrials.gov Identifier: NCT01117168
Recruitment Status : Terminated
First Posted : May 5, 2010
Last Update Posted : October 6, 2017
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Brief Summary:

Background:

- The Children s Oncology Group has established a research network, the Childhood Cancer Research Network (CCRN), to collect information about children with cancer and other conditions that are benign but involve abnormal cell growth in order to help doctors and scientists better understand childhood cancer. The CCRN's goal is to collect clinical information about every child diagnosed with cancer and similar conditions in the United States and Canada, to allow researchers to study patterns, characteristics, and causes of childhood cancer. The information can also help researchers study the causes of childhood cancer. To expand the CCRN, parents of children who have been diagnosed with cancer will be asked to provide information about themselves and their child for research purposes.

Objectives:

  • To obtain informed consent from parents (and the child, when appropriate) of infants, children, adolescents, and young adults newly diagnosed with cancer to enter their names and certain information concerning their child into the Childhood Cancer Research Network.
  • To obtain informed consent from parents (and the child, when appropriate) of infants, children, adolescents, and young adults newly diagnosed with cancer for permission to be contacted in the future to consider participating in non-therapeutic and prevention research studies involving the parents and/or the child.

Eligibility:

- Parents of children who have been seen at or treated by a hospital that is a member of the Children s Oncology Group.

Design:

  • Parents will provide permission to have personal information sent from their child s hospital to the CCRN, including the child and parents' names; child's gender, birth date, race, and ethnicity; information about the disease; and the treating institution.
  • Parents will also give permission for CCRN to contact the diagnostic laboratory to obtain specific information about the tumor or cancer cells.
  • Parents will be asked if they are willing to be contacted in the future to consider participating in CCRN research studies, and will provide contact information (name, home address, and telephone number) to be entered in the CCRN.
  • Parents or patients who change their minds about having information available in the CCRN can ask the treatment institution to restrict access to the identifying information. Parents or patients who refuse to have information included in the CCRN or be contacted in the future will still be able to enter clinical cancer research studies.

Condition or disease
Pediatric Cancer Leukemia Sarcoma Brain Tumors

  Hide Detailed Description

Detailed Description:

Background:

  • Institutional membership in the Children s Oncology Group (COG) requires registration of all pediatric cancer patients seen at their site. This registration process includes all patients.
  • In order to maximize the resource that a network would provide, it is necessary to have identifying information on a large proportion of the cases included within the network. Moreover, the resource would be further enhanced if informed consent from parents/patients was obtained to allow future contact regarding possible participation in non-therapeutic and prevention research.

Objectives:

  • 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 into the Childhood Cancer Research Network and/or for permission to be contacted in the future to consider participating in future studies.
  • 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 and/or to be possibly contacted in the future to consider participating in other studies.

Eligibility:

  • Pre-CCRN Entry
  • 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).

  • -All lesions of the central nervous system regardless of behavior, i.e., benign, borderline or malignant.

    • 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

Design:

If consent to enter the patient in ACCRN07 is obtained:

  1. Using the patient s COG ID, the CCRN consent will be added to their record and the patient will be considered registered with COG.
  2. Depending on the response on the consent form, the record will be flagged for a yes or no to possible contact for future studies in the CCRN.

If consent is not obtained to enter the patient in ACCRN07

  1. For those parents/patients who refuse the CCRN consent, they will still be able to be enrolled on any COG clinical trial (therapeutic and non- therapeutic) for which the patient is eligible. The unique COG ID will be used to identify the patient.
  2. The information collected as part of the study entry procedures will not be available to the CCRN. The record will be flagged as refusing participation in the CCRN.
  3. If consent is later obtained for enrollment in the CCRN, the patient must be entered in ACCRN07 using the patient s unique COG ID.

Study Type : Observational
Actual Enrollment : 4 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Protocol for the Enrollment on the Official COG Registry, The Childhood Cancer Research Network (CCRN) Children s Oncology Group
Study Start Date : April 30, 2010
Study Completion Date : August 9, 2017

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. To collect information on children with cancer [ Time Frame: After initial diagnosis ]

Secondary Outcome Measures :
  1. To obtain consent to contact in the future for participation in future clinical trials [ Time Frame: At enrollment and at age of majority ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:
  • Pre-CCRN Entry
  • 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).
    • All lesions of the central nervous system regardless of behavior, i.e., benign, borderline or malignant.
    • 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01117168


Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Brigitte C Widemann, M.D. National Cancer Institute (NCI)

Publications:
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01117168     History of Changes
Obsolete Identifiers: NCT00799253
Other Study ID Numbers: 100111
10-C-0111
First Posted: May 5, 2010    Key Record Dates
Last Update Posted: October 6, 2017
Last Verified: August 9, 2017

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Children's Oncology Group
Pediatric Oncology
Pediatric Cancer
Registration
Leukemia
Brain Tumor
Sarcoma

Additional relevant MeSH terms:
Sarcoma
Brain Neoplasms
Neoplasms
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases