Follow-Up Protocol for Subjects Previously Enrolled on NCI Surgery Branch Studies
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 1,150
- 试验地点
- 1
- 主要终点
- Long-term follow-up
研究概览
简要总结
Background:
The NCI Surgery Branch has developed experimental therapies that involve taking white blood cells from participants' tumor or from their blood, growing them in the laboratory in large numbers, and then giving the cells back to the patient.
Objective:
This study will allow participants to be followed for up to 15 years following treatment on an NCI Surgery Branch Gene Therapy Trial as required by the FDA.
Eligibility:
Participants must have been enrolled on an NCI Surgery Branch Gene Therapy Protocol
Design
Participants will be followed with a physical examination and blood tests for up to 15 years as required by the FDA
详细描述
Background:
- Patients receiving care at the NIH Clinical Center are required to be enrolled on a clinical protocol.
- Following participation in a treatment protocol, it may be in the best interest of the patient to continue to be followed at the Clinical Center.
- The National Cancer Institute Surgery Branch (NCI-SB) conducts clinical trials utilizing gene transfer. The current U.S. Food and Drug Administration (FDA) requirements for long-term follow-up are up to fifteen years for some products. As this time-period is frequently longer than studies are expected to be open, a long-term follow-up protocol is necessary to ensure the follow-up of these participants.
Objective:
-Primary objective:
--Provide a mechanism for long-term follow-up of participants who have participated in research studies in the NCI-SB.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •INCLUSION CRITERIA:
- •Age greater than or equal to 18 years.
- •Participants who have received treatment on an NCI-SB protocol, including gene therapy protocols. (Note: Participants may be enrolled on this protocol and, at the same time, participate in an active treatment study).
- •For Cohort A:Ability of participant or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document. For Cohort B: Participant is able to provide informed consent.
排除标准
- •For Cohort B: Individuals of child-bearing potential (IOCBP) who are pregnant or plan to become pregnant because of the potentially dangerous effects of the investigational treatments administered on NCI-SB treatment protocols.
研究组 & 干预措施
A/Gene Therapy
Patients who have received gene therapy
B/Non-Gene Therapy
Patients who have not received gene therapy
结局指标
主要结局
Long-term follow-up
时间窗: Until time of death
Long-term follow-up of subjects who have participated in research studies in the NCI Surgery Branch
次要结局
- Long-term follow-up for gene therapy studies(15 years)
- Survival(Until time of death)