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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01117168
Other study ID # 100111
Secondary ID 10-C-0111
Status Terminated
Phase N/A
First received May 4, 2010
Last updated October 5, 2017
Start date April 30, 2010
Est. completion date August 9, 2017

Study information

Verified date August 9, 2017
Source National Institutes of Health Clinical Center (CC)
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Other known NCT identifiers
  • NCT00799253

Recruitment information / eligibility

Status Terminated
Enrollment 4
Est. completion date August 9, 2017
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group N/A to 18 Years
Eligibility - 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 Design


Locations

Country Name City State
United States National Institutes of Health Clinical Center, 9000 Rockville Pike Bethesda Maryland

Sponsors (1)

Lead Sponsor Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary To collect information on children with cancer After initial diagnosis
Secondary To obtain consent to contact in the future for participation in future clinical trials At enrollment and at age of majority
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