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

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

Tracking Information

• First Submitted Date: May 4, 2010
• First Posted Date: May 5, 2010
• Last Update Posted Date: October 6, 2017
• Study Start Date: April 30, 2010
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures (submitted: October 18, 2014): To collect information on children with cancer [ Time Frame: After initial diagnosis ]
• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures (submitted: October 18, 2014): To obtain consent to contact in the future for participation in future clinical trials [ Time Frame: At enrollment and at age of majority ]
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Enrollment on the Childhood Cancer Research Network (CCRN) of the Children s Oncology Group
• Official Title: Protocol for the Enrollment on the Official COG Registry, The Childhood Cancer Research Network (CCRN) Children s Oncology Group

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.

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
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Not Provided
• Study Population: Not Provided

Condition

• Pediatric Cancer
• Leukemia
• Sarcoma
• Brain Tumors

• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided
• Publications *: Ross JA, Severson RK, Pollock BH, Robison LL. Childhood cancer in the United States. A geographical analysis of cases from the Pediatric Cooperative Clinical Trials groups. Cancer. 1996 Jan 1;77(1):201-7. doi: 10.1002/(SICI)1097-0142(19960101)77:13.0.CO;2-7.

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: August 10, 2017): 4
• Original Estimated Enrollment (submitted: May 4, 2010): 80
• Study Completion Date: August 9, 2017
• Primary Completion Date: Not Provided

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: up to 18 Years (Child, Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01117168
• Other Study ID Numbers: 100111; 10-C-0111
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
• Original Responsible Party: Not Provided
• Current Study Sponsor: National Cancer Institute (NCI)
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Brigitte C Widemann, M.D.; National Cancer Institute (NCI)

• PRS Account: National Institutes of Health Clinical Center (CC)
• Verification Date: August 9, 2017