Eligibility Screening for a NCI Pediatric Oncology Branch Research Study
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Cancer, Other Indications, Brain Cancer, Blood Cancer |
| Therapuetic Areas: | Oncology, Other |
| Healthy: | No |
| Age Range: | Any - 35 |
| Updated: | 4/6/2019 |
| Start Date: | April 18, 2001 |
Eligibility Screening and Tissue Procurement for the National Cancer Institute (NCI), Pediatric Oncology Branch (POB) Clinical Research Protocols
Patients who are being considered for participation in a NCI Pediatric Oncology Branch
research study will be screened for eligibility under this protocol. For every NCI research
study, patients must meet defined medical criteria in order to ensure the integrity of the
research study and to maximize patient safety.
Tests and procedures required for determining eligibility depend on the specific study for
which the patient is being considered. Some of the more common tests and procedures are:
- History and physical examination
- Blood and urine samples for routine laboratory tests and possibly research studies
- Quality of life assessment questionnaire
- Magnetic resonance imaging (MRI) scan uses a magnetic field and radio waves to produce
pictures of body structures, including tumors
- Computerized tomography (CT) scan uses radiation to produce multiple detailed pictures
of body structures
- X-rays uses radiation to provide a single picture of a body part
- Nuclear medicine scans uses a chemical tagged with a radioactive substance to detect
tumors, measure kidney or heart function, or monitor the flow of cerebrospinal fluid
(fluid that bathes the brain and spinal cord)
- Electrocardiogram (EKG) uses electrodes placed on the skin to evaluates heart rate and
rhythm by measuring electrical impulses from the heart
- Echocardiogram uses high-frequency sound waves to evaluate heart structure and function
- Lumbar puncture tests for cancer cells and other substances in cerebrospinal fluid.
Involves placing a needle into the lower back between the bones of the spine and
withdrawing a fluid sample from the fluid-containing space below the spinal cord
- Ommaya reservoir surgically implanted catheter inserted into the fluid-filled ventricles
of the brain, used to withdraw spinal fluid samples and to give medication
- Eye examination vision test and eye examination
- Biopsies removal of a small piece of tissue, by needle or by surgery, for examination
under the microscope. An area of skin over the biopsy site is numbed with an anesthetic.
For a needle biopsy, a needle is inserted into the tumor, tissue or bone marrow to pull
out a small sample. A surgical biopsy may be done in the operating room, clinic, or
hospital room, depending on the biopsy location. The tissue or tumor is removed by
cutting a small piece of it with a sharp knife or scalpel and the area will be closed
with sutures or staples.
research study will be screened for eligibility under this protocol. For every NCI research
study, patients must meet defined medical criteria in order to ensure the integrity of the
research study and to maximize patient safety.
Tests and procedures required for determining eligibility depend on the specific study for
which the patient is being considered. Some of the more common tests and procedures are:
- History and physical examination
- Blood and urine samples for routine laboratory tests and possibly research studies
- Quality of life assessment questionnaire
- Magnetic resonance imaging (MRI) scan uses a magnetic field and radio waves to produce
pictures of body structures, including tumors
- Computerized tomography (CT) scan uses radiation to produce multiple detailed pictures
of body structures
- X-rays uses radiation to provide a single picture of a body part
- Nuclear medicine scans uses a chemical tagged with a radioactive substance to detect
tumors, measure kidney or heart function, or monitor the flow of cerebrospinal fluid
(fluid that bathes the brain and spinal cord)
- Electrocardiogram (EKG) uses electrodes placed on the skin to evaluates heart rate and
rhythm by measuring electrical impulses from the heart
- Echocardiogram uses high-frequency sound waves to evaluate heart structure and function
- Lumbar puncture tests for cancer cells and other substances in cerebrospinal fluid.
Involves placing a needle into the lower back between the bones of the spine and
withdrawing a fluid sample from the fluid-containing space below the spinal cord
- Ommaya reservoir surgically implanted catheter inserted into the fluid-filled ventricles
of the brain, used to withdraw spinal fluid samples and to give medication
- Eye examination vision test and eye examination
- Biopsies removal of a small piece of tissue, by needle or by surgery, for examination
under the microscope. An area of skin over the biopsy site is numbed with an anesthetic.
For a needle biopsy, a needle is inserted into the tumor, tissue or bone marrow to pull
out a small sample. A surgical biopsy may be done in the operating room, clinic, or
hospital room, depending on the biopsy location. The tissue or tumor is removed by
cutting a small piece of it with a sharp knife or scalpel and the area will be closed
with sutures or staples.
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.
- 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:
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
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