Eligibility Screening for a NCI Pediatric Oncology Branch Research Study

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 becollected during the screening process to prevent subjecting 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, HLA, IHC, 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 OHSRP.

• INCLUSION CRITERIA:

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

All patients or their legal guardians (if the patient is less than 18 years of age) must sign a document of informed consent indicating their understanding of the research nature and the risks of the procedures that will be performed to assess eligibility for primary research protocols.

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.

Exclusion criteria

None.