Protocol Number: 01-C-0157

Title:

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

Number:

01-C-0157

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.

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): None

Eligibility Criteria:

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. When appropriate, pediatric patients (less than 18 years of age) will be included in all discussions in order to obtain verbal assent..

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.

A Durable Power of Attorney (DPA) will be offered to all patients greater than or equal to 18 years of age who have a brain tumor or meningeal tumor involvement.

EXCLUSION CRITERIA:

None.

Special Instructions:

Currently Not Provided

Keywords:

CT Scan

MRI

Children

Nuclear Medicine

Blood Tests

Recruitment Keyword(s):

Pediatric

Children

Screening

Condition(s):

Neoplasm

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

None

Supporting Site:

National Cancer Institute

Contact(s):

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
Phone: 1-888-NCI-1937
Fax: Not Listed
Electronic Address: ncicssc@mail.nih.gov

Citation(s): Not Provided

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Networks and Applications, CC.

Search The Studies | Help | Questions |
Clinical Center Home | NIH Home

National Institutes of Health Clinical Center Bethesda, Maryland 20892. Last update: 09/15/2008