Screening Protocol for Subjects Being Evaluated for National Heart, Lung and Blood Institute (NHLBI) Protocols
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- Primary endpoint is the results of clinical, imaging and laboratory assessments.
研究概览
简要总结
This study allows the evaluation of subjects in order to determine their ability to safely participate in other active research studies.
After subjects complete the screening process, they will be offered the opportunity to participate in an active research study, or if no appropriate studies are available information and recommendations will be provided for other treatment options....
详细描述
This protocol is designed for screening of subjects before a decision can be made as to their eligibility for one of the active National Heart, Lung, and Blood Institute (NHLBI) research protocols. Its purpose is to allow detailed investigation into the hematologic or oncologic problems of these subjects, and the status of other organ systems that would determine their ability to safely tolerate specific aspects of active research protocols. It allows investigation as to whether a donor is HLA matched, fit to receive G-CSF, and fit to undergo apheresis and therefore eligible to participate as a donor on a bone marrow transplant protocol. It also allows the investigation as to whether subjects are eligible for participation as normal volunteer based on protocol eligibility criteria that requires generally good health status by history or physical exam findings, or laboratory assessments. After completion of this screening process, the subject will either be offered a chance to participate in an active research protocol, or if no appropriate protocol is identified, subjects with hematologic or oncologic disease will have recommendations for other treatment options relayed to the primary or referring physician.
Primary objective is to determine subject eligibility for participation on NHLBI protocols.
Primary endpoint is the results of clinical, imaging and laboratory assessments.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 2 Years 至 100 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •INCLUSION CRITERIA:
- •Subjects will be entered on this protocol at the time of their first visit to the NIH Clinical Center outpatient clinic or inpatient service if:
- •The subject carries the diagnosis of a disorder for which the NHLBI has an active research protocol, and based on information received from an outside physician, he/she appears to meet at least preliminary eligibility criteria for that protocol
- •The subject is a donor for a subject for whom the NHLBI has an active stem cell transplant protocol and based on information received from an outside physician, he/she appears to meet preliminary eligibility as a donor
- •The subject is a normal volunteer for whom the NHLBI has an active study recruiting healthy normal volunteers and he/she appears to meet preliminary eligibility as a normal volunteer
- •Age >= 2 and Weight >12 kg (healthy volunteers age >=8)
- •The subject, the subject's guardian (if the subject is a minor), or the subject's legally authorized representative (LAR) is capable of informed consent, and willing to sign the consent form after initial counseling by clinical staff. Separate consent forms for all interventional or surgical procedures will be obtained after explanation of the specific procedure.
排除标准
- •All subjects not fulfilling the inclusion criteria will be considered ineligible.
研究组 & 干预措施
Subjects undergoing screening
Adults and children being screened for an active NHLBI protocol
结局指标
主要结局
Primary endpoint is the results of clinical, imaging and laboratory assessments.
时间窗: ongoing
Results of clinical, imaging and laboratory assessments
次要结局
未报告次要终点