Patient Registry for Prospective Research on Evolving Radiation Oncology Techniques and Quality
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Numbers of patients experiencing toxicities/adverse events both during and at follow-up after radiation therapy with any of 11 therapeutic modalities.
研究概览
简要总结
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.
详细描述
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
- •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.
排除标准
- •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
结局指标
主要结局
Numbers of patients experiencing toxicities/adverse events both during and at follow-up after radiation therapy with any of 11 therapeutic modalities.
时间窗: 5 years
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.
次要结局
- Numbers of men and women who experience short- and long-term toxicities after specific radiation treatments.(5 years)
- Age differences in short- and long-term toxicities associated with specific radiation treatment modalities.(5 years)
- Patient income differences in short- and long-term toxicities associated with specific radiation treatment modalities.(5 years)
- Numbers of patients with different initial diagnoses associated with short- and long-term toxicities with specific radiation treatments.(5 years)
研究者
Department of Radiation Oncology
Principle Investigator
University of Maryland, Baltimore