Evaluation of Late Effects and Natural History of Disease in Patients Treated With Radiotherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- Assessment of the late effects of treatment and the natural history of disease
研究概览
简要总结
BACKGROUND
- This protocol acknowledges that it is in the interest of the NIH and ROB, as well as our participants, to continue to follow those who have been treated with radiotherapy at ROB and are not otherwise eligible for current active research protocols.
- It also provides a mechanism for the correlation and interpretation of disparate data for research into the long term side effects and outcomes for a variety of disease entities and treatments, such as combined modality treatment, MoAb, PDT, radiation modifiers,
intraoperative radiotherapy, etc.
OBJECTIVE
-The primary objective of this protocol is to assess the late effects of treatment and the natural history of disease through collection of data from any standard procedures performed as part of follow up care on participants previously treated with radiotherapy.
ELIGIBILITY
-Participants who received radiation therapy.
DESIGN
- This is a natural history protocol in which long-term follow up data will be collected from participants who received radiation therapy.
- It will be made clear to participants in the consent form, that data collected during their follow-up may be used anonymously for publications concerning the natural history of disease processes and long-term effects of treatment.
详细描述
BACKGROUND
- This protocol acknowledges that it is in the interest of the NIH and ROB, as well as our participants, to continue to follow those who have been treated with radiotherapy at ROB and are not otherwise eligible for current active research protocols.
- It also provides a mechanism for the correlation and interpretation of disparate data for research into the long term side effects and outcomes for a variety of disease entities and treatments, such as combined modality treatment, MoAb, PDT, radiation modifiers,
intraoperative radiotherapy, etc.
OBJECTIVE
-The primary objective of this protocol is to assess the late effects of treatment and the natural history of disease through collection of data from any standard procedures performed as part of follow up care on participants previously treated with radiotherapy.
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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •INCLUSION CRITERIA:
- •ROB investigator deems that it is in the best interests of the participant and the NCI/ROB for the participant to be seen in follow-up in the ROB clinic.
- •Participant is able to provide informed consent.
- •Participant must have a primary physician in the community to whom records and appropriate follow-up management can be given. Social services will be enlisted for any participants who lack health insurance, etc.
- •Participants who have received radiotherapy.
- •Age greater than or equal to 18 years of age
排除标准
- •Participants who are on an interventional research protocol at NIH at the time of enrollment.
研究组 & 干预措施
1/Cohort 1
Patients who have received radiotherapy in the ROB and may or may not be officially entered on a clinical protocol.
结局指标
主要结局
Assessment of the late effects of treatment and the natural history of disease
时间窗: Ongoing
Description of late effects of radiation treatment and the natural history of diseases being studied.
次要结局
未报告次要终点