RADTOX: Measuring Radiation Toxicity Using Circulating DNA (RADTOX)
研究概览
详细说明
Currently, a patient's risk for toxicity is based almost exclusively on population statistics. Radiation (and chemotherapy) dose are based on phase I data and not on the individual's specific genetics or hidden predispositions. RadTox measures cell damage within 24 hours of radiation exposure and should help identify patients at higher risk for radiation complications. This should allow physicians to adjust radiation field size and dose to minimize long-term toxicity.
Patients undergoing radiation treatment for stage I to III prostate cancer, using protons or X-rays, either as primary treatment or consolidation after prostatectomy (positive margins or prostate-specific assay [PSA]-related indications) will be eligible. Hormone treatment will be allowed.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Florida
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Gainesville、Florida、美国、32610
- University of Florida Health
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Jacksonville、Florida、美国、32206
- University of Florida Health Proton Therapy Institute
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Consent to participate in the study and a signed and dated an institutional review board (IRB)-approved consent form conforming to federal and institutional guidelines.
- ≥ 18 years of age.
- Patients must have an Eastern Cooperative Oncology Group (An ECOG) performance status of 0 or 1.
- A diagnosis of adenocarcinoma of the prostate.
- Not yet begun definitive therapy with chemotherapy or radiation but may have hormones or surgery.
- Clinically stage I to III tumors.
Exclusion Criteria:
- Metastatic disease.
- A history of invasive rectal malignancy or other pelvic malignancy, regardless of disease-free interval.
- Active inflammatory bowel disease (i.e., patients requiring current medical interventions or who are symptomatic).
- Prior pelvic radiation therapy for any reason.
- Psychiatric or addictive disorders or other conditions that, in the opinion of the principal investigator (PI), would preclude the patient from meeting the study requirements.
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Evaluate toxicity biomarkers
Investigators will determine if measurement of circulating DNA from tumor and normal tissues shortly after RT provides an early and quantitative measure of risk of radiation-related complications.
It will be necessary to collect blood specimens prior to and during the first week of radiation therapy.
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Plasma blood collection is collected at specific intervals prior to and during radiation treatment.
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Free circulating DNA will be measured in patients undergoing radiation for prostate cancer as a toxicity biomarker compared to CTCAE v4.0
大体时间:9 Months
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9 Months
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Free circulating DNA will be measured in patients undergoing radiation for prostate cancer as a toxicity biomarker compared pain scores
大体时间:9 Months
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9 Months
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Free circulating DNA will be measured in patients undergoing radiation for prostate cancer as a toxicity biomarker compared and visual analog scales of toxicity
大体时间:9 Months
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9 Months
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合作者和调查者
调查人员
- 首席研究员:Randal Henderson, MD, MBA、clinical professor
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- IRB201601961-N
- 261201600063C-0-0-1 (美国 NIH 拨款/合同)
- OCR15535 (其他标识符:OnCore)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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