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RADTOX: Measuring Radiation Toxicity Using Circulating DNA (RADTOX)

2019年8月28日 更新者:University of Florida
This research study is being done to develop a new test to identify prostate cancer patients at highest risk of radiotherapy-related complications. This research study would allow monitoring of total tissue damage within 24 hours of radiation exposure in blood samples that could give an initial result within a few days that would help clinicians make treatment decisions. Detection of unusual tissue damage at this early time, well before symptoms occur, could allow doctors to tailor interventions that could include patient therapies that would reduce or prevent the problems that occur due to treatment of their cancer.

研究概览

地位

完全的

条件

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

观察性的

注册 (实际的)

68

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Florida
      • Gainesville、Florida、美国、32610
        • University of Florida Health
      • Jacksonville、Florida、美国、32206
        • University of Florida Health Proton Therapy Institute

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

男性

取样方法

非概率样本

研究人群

Male patients with undergoing radiation therapy for prostate cancer

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

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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
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.
Plasma blood collection is collected at specific intervals prior to and during radiation treatment.
其他名称:
  • Plasma/Blood Collection

研究衡量的是什么?

主要结果指标

结果测量
大体时间
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
9 Months

次要结果测量

结果测量
大体时间
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
9 Months
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
9 Months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Randal Henderson, MD, MBA、clinical professor

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2016年10月1日

初级完成 (实际的)

2017年3月1日

研究完成 (实际的)

2017年7月1日

研究注册日期

首次提交

2016年10月13日

首先提交符合 QC 标准的

2016年10月20日

首次发布 (估计)

2016年10月21日

研究记录更新

最后更新发布 (实际的)

2019年8月29日

上次提交的符合 QC 标准的更新

2019年8月28日

最后验证

2019年8月1日

更多信息

与本研究相关的术语

关键字

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)?

不

IPD 计划说明

Data will be shared with necessary government agencies, the sponsor, and participating providers and institutions as defined in the informed consent document.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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