Pelvic Fractures and Radiation Therapy for Cervical Cancer
Evaluation of Bone Density and Pelvic Fractures in Women Undergoing Definitive Pelvic Radiation Therapy for Cervical, Endometrial or Vaginal Cancer
研究概览
详细说明
If you agree to take part in this study, the following tests and procedures will be performed before radiation therapy:
- You will have a bone mineral density test. A bone mineral density test measures bone loss over time, identifies osteoporosis (a disease of the bones that causes them to be weak and easily breakable) or the risk for developing osteoporosis, and checks your risk for fractures. During the test, you will lie on a cushioned table while a mechanical arm-like device will pass over your body. This device will not touch you.
- During your routine visits, you may have either a magnetic resonance imaging (MRI) scan or a computed tomography (CT) scan of the pelvis as part of your standard of care. A PET scan may be done if your doctor thinks it is necessary. These scans will be reviewed by the research staff of this study to determine your response to therapy, determine if your cancer has returned, and to look for broken bones.
- Blood (about 1 tablespoon) will be drawn to test for bone turnover.
- Blood (about 2 to 3 teaspoons) will be drawn for tests to measure the level of vitamin D, calcium, phosphorus, and parathyroid hormone (PTH).
- Researchers will collect information from your medical record. This information will include your medical history, your ethnicity, if you have had any bone fractures, if you have a history of bone fractures in your family, and your use of tobacco and/or alcohol.
At 4 weeks after start of radiation therapy, blood (about 2 to 3 teaspoons) will be drawn to test for bone turnover.
At 3 months, 1 year, and 2 years after you complete radiation:
- You will have a bone mineral density test.
- You may have either an MRI or CT scan of the pelvis as part of your standard of care. A PET scan may be done if your doctor thinks it is necessary. These scans will be reviewed by the research staff of this study to determine your response to therapy, determine if your cancer has returned, and to look for broken bones.
- Blood (about 2 tablespoons) will be drawn for tests to measure the level of vitamin D and to test for bone turnover.
Length of Study:
You will be off study 2 years after you complete radiation.
After 2 years and for up to 5 years, results of bone density tests or scans of the pelvis that you have outside of this study will be collected.
This is an investigational study.
Up to 300 women will take part in the study. All will be enrolled at MD Anderson.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Texas
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Houston、Texas、美国、77030
- University of Texas MD Anderson Cancer Center
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
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:
- Patients with histologically confirmed primary or recurrent cervical , endometrial or vaginal cancer. All stages, grades and histologic subtypes will be eligible except neuroendocrine.
- Patients treated with definitive radiation therapy. Patients receiving extended field radiation or brachytherapy in addition to pelvic radiation are eligible. Patients treated with surgery, chemotherapy and/or hormonal therapy in addition to radiation therapy are also eligible.
- Patients must sign an approved informed consent document.
Exclusion Criteria:
- Patients undergoing palliative intent radiation therapy for advanced disease.
- Patients who received prior radiation to the pelvis.
- Patients with an existing pelvic fracture within the proposed radiation field.
- Patients unwilling or unable to provide informed consent for the study.
- Patients with bone metastases.
- Neuroendocrine features present.
- Patients weighing more than 300 lbs are excluded as they cannot be adequately studied in axial skeleton with current bone mineral density software.
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 |
|---|---|
|
Evaluation Group
Bone Mineral Density Test + MRI or CT + Blood Test
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During routine visits, a magnetic resonance imaging (MRI) scan or a computed tomography (CT) scan. Blood (about 1 tablespoon) will be drawn to test for bone turnover.
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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Change in Patient Bone Mineral Density (BMD)
大体时间:2 years
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2 years
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Incidence of pelvic fractures incidence in women treated with definitive pelvic radiation therapy for cervical, endometrial or vaginal cancer
大体时间:Within 2 years of treatment completion
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Within 2 years of treatment completion
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合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
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
关键字
其他相关的 MeSH 术语
其他研究编号
- 2008-0023
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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