患有慢性退化性关节病并接受 LDRT 的患者血液的免疫分型 (IMMO-LDRT01)
Immunophenotyping From Blood of Patients Suffering From Chronic Degenerating Joint Diseases and Receiving Local Low Dose Radiation Therapy (LDRT)
Patients suffering from chronic degenerating diseases are often treated by a plethora of NSAIDs, DMARDs, Biologicals, as well as combinations of these therapeutics. However, many patients are refractory to this treatment and suffer from chronic pain over years, leading to a worsening of the quality of live. The mobilization of these patients is one main goal in the therapy of these chronic and inflammatory diseases. Low dose radiation therapy (LDRT) is applied since more than one century for the local treatment of chronic degenerating joint diseases. The success of the treatment was described by many retrospective as well as pattern of care studies, respectively.
Local (only at the painful joint) low dose irradiation of the chronic patients results in most patients in a significantly reduced pain, not only direct after the therapy, but also lasting for more than 12 month in many cases. The patients experience enhanced mobility and increased quality of life. The molecular and cellular processes leading to the pain reduction are just fragmentarily analyzed. Our group revealed that macrophages are key players in radiation-induced immune modulation. Inflammatory macrophages exposed to low doses of radiation showed a reduced inflammatory capacity and attenuated an inflammatory microenvironment. Besides macrophages further immune cells are most likely involved in reduction of inflammation following LD-RT, as in vitro already shown for neutrophils.
The IMMO-LDRT01 study aims for the first time to analyze in detail the immune status of patients suffering from inflammatory, chronic joint diseases before, during and after LD-RT in a longitudinal manner. The multi-color flow cytometry-based assay will allow determining over 30 immune cell subsets and additionally their activation status. Further, biodosimetry will be performed with the whole-blood samples to get hints about dose that the immune cells are exposed to. This will be performed with national and international co-operation partners.
The IMMO-LDRT01 study is a prospective and observational study not influencing the standard therapeutic scheme and will provide hints how the LDRT affects besides local cells in the irradiated area also the systemic inflammatory response.
研究概览
研究类型
注册 (预期的)
联系人和位置
学习联系方式
- 姓名：Benjamin Frey, PhD
- 电话号码：+49 9131 85 44248
- 邮箱：benjamin.frey@uk-erlangen.de
学习地点
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Bavaria
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Erlangen、Bavaria、德国、91054
- 招聘中
- Department of Radiation Oncology, Universitätsklinikum Erlangen
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接触：
- Benjamin Frey, PhD
- 电话号码：+49 91 31 85 44248
- 邮箱：benjamin.frey@uk-erlangen.de
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接触：
- Marga Lang-Welzenbach, M.A.
- 电话号码：+49 91 31 85 33968
- 邮箱：st-studiensekretariat@uk-erlangen.de
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
Patients suffering from chronic inflammatory diseases of the joints, namely painful shoulder syndrome (periarthritis humeroscapularis), painful elbow syndrome (Epicondylopathia humeri), benign achillodynia, benign calcaneodynia, arthosis (finger- , rhiz-, gon-, and anklearthrosis, and arthritis (gon- and anklearthrosis).
Patients were attributed to our clinic and the study protocol was explained in detail. The patients have to give their informed consent before starting with the LDRT. The treatment-plan of the underlying disease remained unchanged. This treatment scheme is conducted with 2 irradiations within 7 days for total treatment duration of 3 weeks. The single dose is 0.5 Gy and the complete dose of one round of LDRT is 3 Gy.
描述
Inclusion Criteria:
- Patients suffering and diagnosed for:
- painful shoulder syndrome (periarthritis humeroscapularis)
- painful elbow syndrome (Epicondylopathia humeri)
- benign achillodynia
- benign calcaneodynia
- arthosis (finger- , rhiz-, gon-, and anklearthrosis
- arthritis (gon- and anklearthrosis)
- Planned local low dose radiation therapy (LDRT) at the Department of Radiation Oncology, Universitätsklinikum Erlangen.
- Age at least 18 years
Exclusion Criteria:
- patients who are suffering or had suffered from any malignant diseases
- fertile patients who refuse effective contraception during study treatment
- persistent drug and/or alcohol abuse
- patients not able or willing to behave according to study protocol
- patients in care
- patients that are not able to speak German
学习计划
研究是如何设计的？
设计细节
- 观测模型：仅案例
- 时间观点：预期
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Study Cohort
Blood draw and Questionaire from patients suffering from chronic inflammatory diseases of the joints, namely painful shoulder syndrome (periarthritis humeroscapularis), painful elbow syndrome (Epicondylopathia humeri), benign achillodynia, and benign calcaneodynia, Arthrosis (finger- and Rhizarthrosis, Gonarthrosis, Anklearthrosis), and Arthritis with an planned local low dose radiation therapy (LDRT) at the Department of Radiation Oncology, Universitätsklinikum Erlangen.
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The study is observational.
The treatment-plan of the underlying disease remained unchanged.
Blood draw from patients at several time points during and after low dose radiation therapy.
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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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Change of circulating immune cells of treated patients by deep immunophenotyping.
大体时间：up to 3 month after completion of RT
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Immunophenotyping of the patients: Detection of about 30 distinct immune sell (sub)types together with their activation markers.
The analyses are conducted at time points before (day 0) and after low dose radiation therapy (day 21): before LDRT (day 0), end of first round of LDRT (last day of LDRT, usually at 3 Gy), and 3 month (day 111) after completed RT.
This scheme is repeated if patient receives additional round of LDRT for relapse treatment.
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up to 3 month after completion of RT
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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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Change of joint pain intensity of the treated patients.
大体时间：up to 9 month after completion of RT
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Analysis of the pain by VAS (visaul Analog Scale; 0 - lowest pain intensity, 10 highest pain intensity) at time points before and after low dose radiation therapy: before LDRT (day 0), end of first round of LDRT (last day of LDRT, usually at 3 Gy), and 3 month (day 111) after completed RT.
This scheme is repeated if patient receives additional round of LDRT for relapse treatment.
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up to 9 month after completion of RT
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接受治疗的患者日常生活中功能能力的变化
大体时间：up to 9 month after completion of RT
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通过 FFbH-R（Funktionsfragebogen Hannover，100% 正常到 10% 几乎完全受限）问卷分析低剂量放射治疗前后时间点的日常生活功能能力：LDRT 之前（第 0 天），第一轮放疗结束LDRT（LDRT 的最后一天，通常为 3 Gy）和完成 RT 后 3 个月（第 111 天）。
如果患者接受额外一轮的 LDRT 以进行复发治疗，则重复该方案。
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up to 9 month after completion of RT
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Change of health-related quality of life
大体时间：up to 9 month after completion of RT
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Analysis of the health-related quality of life by EQ5DL (health index value) questionnaire at time points before and after low dose radiation therapy: before LDRT (day 0), end of first round of LDRT (last day of LDRT, usually at 3 Gy), and 3 month (day 111) after completed RT.
This scheme is repeated if patient receives additional round of LDRT for relapse treatment.
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up to 9 month after completion of RT
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description of pain quality
大体时间：up to 9 month after completion of RT
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Analysis of the pain by descriptive questionnaire at time points before and after low dose radiation therapy: before LDRT (day 0), end of first round of LDRT (last day of LDRT, usually at 3 Gy), and 3 month (day 111) after completed RT.
This scheme is repeated if patient receives additional round of LDRT for relapse treatment.
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up to 9 month after completion of RT
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合作者和调查者
调查人员
- 首席研究员：Oliver J Ott, MD、Department of Radiation Oncology, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg
- 首席研究员：Udo S Gaipl, PhD、Department of Radiation Oncology, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg
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
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
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