Prospective Patient Registry for Radiation Oncology Techniques and Quality (GCC 1490)
2019年9月10日 更新者：Department of Radiation Oncology、University of Maryland, Baltimore
Patient Registry for Prospective Research on Evolving Radiation Oncology Techniques and Quality
This study will create a patient data registry to collect and analyze information on technology usage and outcomes among patients receiving a broad range of relatively new radiation treatments that have become standards of care in our practice.
Review of this information will serve as a basis for development of better patient management plans, to inform decisions about acquisition of new technologies, to provide information about quality in our care delivery, and to create a database that will securely warehouse ongoing information about what treatments the patients we serve need most and the challenges they face in the treatment process.
The information gathered is likely to not only improve our services at the University of Maryland and its community sites but to advance medical science and enhance the quality of care for cancer patients.
研究概览
详细说明
The purpose of this study is to create a robust and long-term patient data registry containing limited demographic, diagnostic, treatment, and follow-up data on patients at the study sites undergoing one or more of the following radiation treatments/technologies:
Brachytherapy, including High-Dose-Rate and Low-Dose-Rate Techniques/ GammaPod Therapy/ GRID Treatment/ Image-Guided Radiation Therapy/ Intensity-Modulated Radiation Therapy and Intensity-Modulated Arc Therapy/ MammoSite and SAVI Applicator/ Photodynamic Therapy/ Proton Therapy/ SIR Spheres and Radiolabeled Microsphere Therapy/ Stereotactic Radiosurgery and Stereotactic Body Radiotherapy/ Thermal Therapy (Hyperthermia)
研究类型
观察性的
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
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Maryland
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Baltimore、Maryland、美国、21201
- Ummc Msgcc
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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
全部
取样方法
非概率样本
研究人群
Primary care clinic
描述
Inclusion Criteria:
- Patients who are 18 years old or older and scheduled to undergo any of the listed radiation treatment technologies at the University of Maryland Medical Center or one of its community sites as included in this protocol provided s/he consents to participate.
Exclusion Criteria:
- Patients who are incarcerated or in legal custody are not eligible for this study.
- Patients who are younger than 18 years, are cognitively impaired, or are otherwise unable to provide informed consent.
- Patients who are pregnant
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
- 观测模型：队列
- 时间观点：预期
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Radiation Therapy
Participants receiving one of the 11 listed therapy modalities.
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targeted radiation treatment
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Numbers of patients experiencing toxicities/adverse events both during and at follow-up after radiation therapy with any of 11 therapeutic modalities.
大体时间：5 years
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Records will be assessed to identify per-patient numbers and grades of toxicities and adverse events resulting from radiation treatment for oncologic conditions as graded by treating physicians according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) during the period of radiation treatment and at each regularly scheduled clinical follow-up appointment, for each of the 11 therapeutic modalities listed as interventions.
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5 years
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Numbers of patients with different initial diagnoses associated with short- and long-term toxicities with specific radiation treatments.
大体时间：5 years
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Records will be assessed to identify numbers of patients with specific initial diagnoses (from approximately 100 International Statistical Classification of Diseases and Related Health Problems [ICD 9] malignant neoplasm diagnoses) who experience short- and long-term toxicities after any of the 11 therapeutic modalities listed as interventions.
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5 years
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Numbers of men and women who experience short- and long-term toxicities after specific radiation treatments.
大体时间：5 years
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Records will be assessed to identify numbers of men and women who experience CTCAE-defined levels of toxicity during and after radiation treatment with any of the 11 therapeutic modalities listed as interventions.
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5 years
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Age differences in short- and long-term toxicities associated with specific radiation treatment modalities.
大体时间：5 years
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Records will be assessed to identify numbers of men and women between the ages of 18-30, 31-40, 41-50, 51-60, 61-70, 71-80, 81-90, and ≥90 years who experience CTCAE-defined levels of toxicity during and after radiation treatment with any of the 11 therapeutic modalities listed as interventions.
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5 years
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Patient income differences in short- and long-term toxicities associated with specific radiation treatment modalities.
大体时间：5 years
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Records will be assessed for income (by patient home zip code per U.S. Internal Revenue statistics available at http://www.irs.gov/uac/SOI-Tax-Stats-Individual-Income-Tax-Statistics-ZIP-Code-Data-(SOI)) to identify income level differences and per-patient numbers/ types of CTCAE-defined levels of toxicity during and after radiation treatment with any of the 11 therapeutic modalities listed as interventions.
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5 years
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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：William Regine, MD、UMMC MSGCC Department of Radiation Oncology
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 (预期的)
2018年2月1日
初级完成 (预期的)
2025年1月1日
研究完成 (预期的)
2030年12月1日
研究注册日期
首次提交
2015年1月20日
首先提交符合 QC 标准的
2015年2月13日
首次发布 (估计)
2015年2月20日
研究记录更新
最后更新发布 (实际的)
2019年9月12日
上次提交的符合 QC 标准的更新
2019年9月10日
最后验证
2019年9月1日
更多信息
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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