Eligibility Screening and Tissue Procurement for the National Cancer Institute (NCI), Pediatric Oncology Branch (POB) Clinical Research Protocols
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,720
- 试验地点
- 1
- 主要终点
- Patient eligibility
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 35 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Patient eligibility
时间窗: 1 month
Eligibility
Collect clinical data
时间窗: 1 month
Clinical data to determine eligibility
Procure samples
时间窗: 1 month
Collect specimens to confirm eligibility
次要结局
未报告次要终点
