Patients are referred to the registry by either the
treating physician, an evaluating pathologist, or by a parent (through
Internet information). Institutional Review Board (IRB) approval
is obtained for the registry through the treating physician's institution.
If the treating physician has not submitted the AT/RT registry protocol
to his/hers institution's IRB, parents then may request registry
personnel to mail them a Cleveland Clinic Foundation (CCF) IRB approved
informed consent form, which will have the CCF's IRB approval stamp
on it.
The parent must sign an institution's IRB approved informed consent
form before a child may be entered onto the registry. After the
IRB approved informed consent form is signed and a copy of the signed
consent form is given to the parents, the registry personnel will
be notified and will issue a registry number. Only the registry
number will be used on the AT/RT registry, not names of patients.
Knowledge that is gained from the registry may be published in scientific
journals but will not identify any patient. The treating physician
or parent will then send data to the registry that is listed on
the Data Collection form.
A standardized data sheet, the Data Collection form, is provided
to treating physicians or parents. The data sheet lists the reports
that are to be sent to the registry. The registry requires radiology
reports, operative notes, pathology reports, cytogenetics reports,
discharge summaries, and treatment records in addition to patient
demographics. Registry personnel abstract the information. Follow-up
information on surviving patients is sought twice yearly through
procedures compatible with privacy regulations by registry personnel.
In addition, physicians are asked to consider
sending archived or frozen tumor tissue for molecular genetic analysis
to Dr. Jaclyn A. Biegel at Childrens Hospital of Philadelphi, Division
of Genetics, 1002 Abramson Research Center, 324 South 34th Street,
Philadelphia, PA 19104, USA in a separately consented study.
