Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00026780
Status:
COMPLETED
Last Update Posted:
2020-10-08
First Post:
2001-11-14
Brief Title:
Eligibility Screening for a NCI Pediatric Oncology Branch Research Study
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Eligibility Screening and Tissue Procurement for the National Cancer Institute NCI Pediatric Oncology Branch POB Clinical Research Protocols
Status:
COMPLETED
Status Verified Date:
2020-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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 eg 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 parentsguardians 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 hisher 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 eg 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 parentsguardians 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 hisher 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 01-C-0157 | None | None | None |