Immunophenotyping From Blood of Patients Suffering From Chronic Degenerating Joint Diseases and Receiving LDRT (IMMO-LDRT01)
Immunphänotypisierung aus dem Blut von Patienten, die an chronisch degenerierenden Gelenkerkrankungen leiden und eine lokale Niedrigdosis-Strahlentherapie (LDRT) erhalten
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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Voraussichtlich)
Kontakte und Standorte
Studienkontakt
- Name: Benjamin Frey, PhD
- Telefonnummer: +49 9131 85 44248
- E-Mail: benjamin.frey@uk-erlangen.de
Studienorte
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Bavaria
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Erlangen, Bavaria, Deutschland, 91054
- Rekrutierung
- Department of Radiation Oncology, Universitätsklinikum Erlangen
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Kontakt:
- Benjamin Frey, PhD
- Telefonnummer: +49 91 31 85 44248
- E-Mail: benjamin.frey@uk-erlangen.de
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Kontakt:
- Marga Lang-Welzenbach, M.A.
- Telefonnummer: +49 91 31 85 33968
- E-Mail: st-studiensekretariat@uk-erlangen.de
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
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.
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: Nur Fall
- Zeitperspektiven: Interessent
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
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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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Change of circulating immune cells of treated patients by deep immunophenotyping.
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Change of joint pain intensity of the treated patients.
Zeitfenster: 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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Change of functional capacity in daily life of the treated patients
Zeitfenster: bis zu 9 Monate nach Abschluss des RT
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Analyse der Funktionsfähigkeit im Alltag mittels Fragebogen FFbH-R (Funktionsfragebogen Hannover, 100 % normal bis 10 % nahezu vollständig eingeschränkt) zu Zeitpunkten vor und nach Niedrigdosis-Strahlentherapie: vor LDRT (Tag 0), Ende der ersten Runde von LDRT (letzter Tag der LDRT, normalerweise bei 3 Gy) und 3 Monate (Tag 111) nach abgeschlossener RT.
Dieses Schema wird wiederholt, wenn der Patient eine zusätzliche LDRT-Runde zur Rückfallbehandlung erhält.
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bis zu 9 Monate nach Abschluss des RT
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Change of health-related quality of life
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: Oliver J Ott, MD, Department of Radiation Oncology, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg
- Hauptermittler: Udo S Gaipl, PhD, Department of Radiation Oncology, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Voraussichtlich)
Studienabschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- IMMO-LDRT01
Plan für individuelle Teilnehmerdaten (IPD)
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