Immunophenotyping From Blood of Patients Suffering From Chronic Degenerating Joint Diseases and Receiving LDRT (IMMO-LDRT01)
Immunofenotypering van bloed van patiënten die lijden aan chronische degenererende gewrichtsaandoeningen en lokale lage dosis radiotherapie (LDRT) ondergaan
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Verwacht)
Contacten en locaties
Studiecontact
- Naam: Benjamin Frey, PhD
- Telefoonnummer: +49 9131 85 44248
- E-mail: benjamin.frey@uk-erlangen.de
Studie Locaties
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Bavaria
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Erlangen, Bavaria, Duitsland, 91054
- Werving
- Department of Radiation Oncology, Universitätsklinikum Erlangen
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Contact:
- Benjamin Frey, PhD
- Telefoonnummer: +49 91 31 85 44248
- E-mail: benjamin.frey@uk-erlangen.de
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Contact:
- Marga Lang-Welzenbach, M.A.
- Telefoonnummer: +49 91 31 85 33968
- E-mail: st-studiensekretariat@uk-erlangen.de
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
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.
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: Case-Alleen
- Tijdsperspectieven: Prospectief
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
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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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Change of circulating immune cells of treated patients by deep immunophenotyping.
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Change of joint pain intensity of the treated patients.
Tijdsspanne: 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
Tijdsspanne: tot 9 maanden na voltooiing van RT
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Analyse van de functionele capaciteit in het dagelijks leven door FFbH-R (Funktionsfragebogen Hannover, 100% normaal tot 10% bijna volledig beperkt) vragenlijst op tijdstippen voor en na lage dosis radiotherapie: vóór LDRT (dag 0), einde van de eerste ronde van LDRT (laatste dag van LDRT, meestal bij 3 Gy) en 3 maanden (dag 111) na voltooide RT.
Dit schema wordt herhaald als de patiënt een extra LDRT-ronde krijgt voor behandeling van terugval.
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tot 9 maanden na voltooiing van RT
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Change of health-related quality of life
Tijdsspanne: 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
Tijdsspanne: tot 9 maanden na voltooiing van 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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tot 9 maanden na voltooiing van RT
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Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Oliver J Ott, MD, Department of Radiation Oncology, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg
- Hoofdonderzoeker: Udo S Gaipl, PhD, Department of Radiation Oncology, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
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Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- IMMO-LDRT01
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