- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01117168
Enrollment on the Childhood Cancer Research Network (CCRN) of the Children s Oncology Group
Protocol for the Enrollment on the Official COG Registry, The Childhood Cancer Research Network (CCRN) Children s Oncology Group
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.
Study Overview
Status
Conditions
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:
- Using the patient s COG ID, the CCRN consent will be added to their record and the patient will be considered registered with COG.
- 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
- 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.
- 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.
- 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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Maryland
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Bethesda, Maryland, United States, 20892
- National Institutes of Health Clinical Center, 9000 Rockville Pike
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
- 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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To collect information on children with cancer
Time Frame: After initial diagnosis
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After initial diagnosis
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To obtain consent to contact in the future for participation in future clinical trials
Time Frame: At enrollment and at age of majority
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At enrollment and at age of majority
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 100111
- 10-C-0111
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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