Trial Information

Eligibility Screening and Tissue Procurement for the National Cancer Institute (NCI), Pediatric Oncology Branch (POB) Clinical Research Protocols

BACKGROUND:

- Patients, who are screened for POB research protocols, undergo a series of tests and
procedures to determine protocol eligibility prior to entry onto the primary research
protocol

- In some cases specific research samples required for the primary research protocol may
be collected during the screening process in order to prevent from having to subject
the patient to a painful procedure on multiple occasions.

- Performing invasive procedures for the sole purpose of obtaining tissue specimens or
body fluids for research purposes is often not ethically justifiable in children, yet
these specimens are needed to advance our knowledge of childhood cancers. Therefore, it
is critical to obtain tissue and fluid samples for future research when procedures are
performed for clinical indications.

OBJECTIVES:

- Evaluate patient eligibility for participation in POB research protocols.

- Collect clinical data, such as a medical history and clinical laboratory results that
can serve as baseline values for subsequent research protocols.

- Procure residual tissues or fluids that are remaining from tests or procedures that are
performed for clinical indications (e.g., diagnosis or treatment of the cancer) during
the screening process or during treatment and follow-up on a primary POB research
protocol. These specimens will be transferred to subsequent research protocols for
IRB-approved research studies or stored for future research studies.

ELIGIBILITY:

- Children and young adults who are being evaluated for and treated on protocols within
the Pediatric Oncology Branch.

- Patients or their parents/guardians can refuse to participate in the tissue procurement
portion of this protocol and still participate in the screening for eligibility on POB
research trials.

DESIGN:

- Patients who are being evaluated for POB primary research protocols will be entered
onto this screening and tissue procurement protocol for eligibility screening and
collection of tissue specimens.

- Procedures to be done may include, but are not limited to, laboratory tests on blood,
CSF, urine, or other specimens; pulmonary function tests; TB skin tests (with a
control); subspecialty consultations; molecular diagnostics on tumor tissues such as
PCR for Ewing's or rhabdomyosarcoma, or FISH; radiographic and nuclear medicine
studies, which may require the administration of contrast or a radioisotopic tracer;
and needle or open biopsies for diagnostic purposes.

- Tissues and body fluids that are obtained during or after the screening process or at
any time during treatment and follow-up on a primary POB research protocol will be
discarded or stored for future research purposes with the consent of the patient or
his/her parent or guardian, if the patient is not eligible for or elects not to enroll
on the primary research protocol. These specimens will be stored with patient
identifiers, IRB approval will be requested prior to performing any research with these
tissues or fluids or the samples will have identifiers removed (unlinked) and an
exemption will be requested from OHSR.