Eligibility Screening for a NCI Pediatric Oncology Branch Research Study

NCT00026780 | Completed

• 2 other identifiers: 01015701-C-0157
• Study Type: observational
• Target: 1,720
• Locations: 1 country
• Sites: 1

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.

Conditions

Ewing Sarcoma; Osteosarcoma; Neuroblastoma; Acute Lymphoblastic Leukemia; Neurofibromatosis Type 1

Keywords

CT Scan; MRI Scan; Childhood Cancer; Eligibility Screening; Tissue Procurement; Pediatric; Children; Screening

Outcome Measures

Primary Outcomes (3)

• Patient eligibility

  Eligibility

  1 month

• Collect clinical data

  Clinical data to determine eligibility

  1 month

• Procure samples

  Collect specimens to confirm eligibility

  1 month

Study Arms (1)

Cohort 1

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

Eligibility Criteria

• Age: Up to 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• None.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Sarcoma, Ewing; Osteosarcoma; Neuroblastoma; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Neurofibromatosis 1; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Sarcoma; Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Leukemia, Lymphoid; Leukemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neurofibromatoses; Neurofibroma; Nerve Sheath Neoplasms; Neoplastic Syndromes, Hereditary; Neurocutaneous Syndromes; Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Brigitte C Widemann, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2001
• First Posted: November 15, 2001
• Study Start: September 24, 2001
• Primary Completion: October 7, 2020
• Study Completion: October 7, 2020
• Last Updated: October 8, 2020

Record last verified: 2020-10

Locations

US (1)