Proton and Photon Consortium Registry (PPCR): A Multi Center Registry of Pediatric Patients Treated With Radiation Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5,000
- 试验地点
- 51
- 主要终点
- Establish Registry
研究概览
简要总结
In previous studies, Proton Beam Radiation Therapy (PBRT) has been found to show better results in treating patients with cancer, both because there is better control of where in the body the radiation is directed and because it is associated with less severe long term side effects. However, there is limited published data demonstrating these results. The goal of the Proton and Photon Consortium Registry (PPCR) is to enroll children treated with radiation in order to describe the population that currently receives radiation and better compare the short-term and long-term benefits of different types of radiotherapy. The data collected from this study will help facilitate research on radiation therapy and allow for collaborative research. The PPCR will collect demographic and clinical data that many centers that deliver radiation therapy already collect in routine operations.
详细描述
Once you are enrolled in the study, you will receive treatment, evaluations and follow up care for your type of cancer as determined by your treating physician according to clinical judgment and standard of care for your clinic. All treatments that you receive will be recorded, including all surgeries and chemotherapy given before or after PBRT. Treatment outcomes, like how you respond to treatment, side effects, and progression of your cancer will be collected as the information becomes available. A study coordinator or research nurse at your clinic will perform a chart review annually to update your status in the database. The study doctor will request any new data within the past year from you or your doctor.
We will be collecting the following data for the Registry:
At Screening: The following data will be collected from the time of diagnosis and initial staging:
- Patient demographics, date of birth, gender, race, zip code and insurance status
- Date of diagnosis
- Histologic or clinical diagnosis and staging relevant to diagnosis
- Imaging studies obtained and tumor measurements
- Lab evaluations which include routine blood tests, hormone levels, and any relevant lab results needed to assess you and baseline and follow-up visits
- Referring physician contact information
Treatment Data Collection: The following data regarding treatment will be collected:
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
- — 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligibility Criteria:
- •Patients treated with radiation therapy at one of the participating centers
- •Age < 22 at time of treatment start.
- •Patients may be enrolled regardless of previous local or systemic treatments received prior to enrollment in the PPCR.
- •Patients may be enrolled regardless of other current local or systemic treatments or disease extent.
- •Patients may be enrolled on the PPCR concurrently with another study or clinical trial.
排除标准
- 未提供
研究组 & 干预措施
Pediatric Patients Treated with Protons
Proton Radiation Therapy
干预措施: No intervention (Other)
结局指标
主要结局
Establish Registry
时间窗: 2 years
Establish a registry of pediatric patients treated with proton radiation therapy in the United States
次要结局
- Describe acute and late effects(2 years)
- Describe patterns of care(2 years)
- Establish a cohort of photon-treated patients(2 years)
- Describe patterns of follow-up(2 years)
研究者
Torunn Yock, MD
Principal Investigator
Massachusetts General Hospital