慢性変性関節疾患に罹患し、LDRT を受けている患者の血液からの免疫表現型検査 (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.
調査の概要
研究の種類
入学 (予想される)
連絡先と場所
研究連絡先
- 名前：Benjamin Frey, PhD
- 電話番号：+49 9131 85 44248
- メール：benjamin.frey@uk-erlangen.de
研究場所
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Bavaria
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Erlangen、Bavaria、ドイツ、91054
- 募集
- Department of Radiation Oncology, Universitätsklinikum Erlangen
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コンタクト：
- Benjamin Frey, PhD
- 電話番号：+49 91 31 85 44248
- メール：benjamin.frey@uk-erlangen.de
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コンタクト：
- Marga Lang-Welzenbach, M.A.
- 電話番号：+49 91 31 85 33968
- メール：st-studiensekretariat@uk-erlangen.de
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
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.
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：ケースのみ
- 時間の展望：見込みのある
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change of circulating immune cells of treated patients by deep immunophenotyping.
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change of joint pain intensity of the treated patients.
時間枠：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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治療を受けた患者の日常生活における機能的能力の変化
時間枠：up to 9 month after completion of RT
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低線量放射線療法の前後の時点での FFbH-R (Funktionsfragebogen Hannover、100% 正常から 10% ほぼ完全に制限された) アンケートによる日常生活における機能的能力の分析: LDRT の前 (0 日目)、最初のラウンドの終わりLDRT (LDRT の最終日、通常は 3 Gy)、および RT 完了後 3 か月 (111 日目)。
このスキームは、患者が再発治療のために追加の LDRT を受ける場合に繰り返されます。
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up to 9 month after completion of RT
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Change of health-related quality of life
時間枠：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
時間枠：RT完了後9ヶ月まで
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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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RT完了後9ヶ月まで
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協力者と研究者
捜査官
- 主任研究者：Oliver J Ott, MD、Department of Radiation Oncology, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg
- 主任研究者：Udo S Gaipl, PhD、Department of Radiation Oncology, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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