- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02653079
Immunfenotypning från blod från patienter som lider av kroniska degenererande ledsjukdomar och som får LDRT (IMMO-LDRT01)
Immunfenotypning från blod från patienter som lider av kroniska degenererande ledsjukdomar och som får lokal lågdosstrålningsterapi (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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Förväntat)
Kontakter och platser
Studiekontakt
- Namn: Benjamin Frey, PhD
- Telefonnummer: +49 9131 85 44248
- E-post: benjamin.frey@uk-erlangen.de
Studieorter
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Bavaria
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Erlangen, Bavaria, Tyskland, 91054
- Rekrytering
- Department of Radiation Oncology, Universitätsklinikum Erlangen
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Kontakt:
- Benjamin Frey, PhD
- Telefonnummer: +49 91 31 85 44248
- E-post: benjamin.frey@uk-erlangen.de
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Kontakt:
- Marga Lang-Welzenbach, M.A.
- Telefonnummer: +49 91 31 85 33968
- E-post: st-studiensekretariat@uk-erlangen.de
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
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.
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: Endast fall
- Tidsperspektiv: Blivande
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
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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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Change of circulating immune cells of treated patients by deep immunophenotyping.
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Change of joint pain intensity of the treated patients.
Tidsram: 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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Förändring av funktionsförmåga i det dagliga livet hos de behandlade patienterna
Tidsram: upp till 9 månader efter avslutad RT
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Analys av den funktionella kapaciteten i det dagliga livet med FFbH-R (Funktionsfragebogen Hannover, 100 % normal till 10 % nästan fullständigt begränsad) frågeformulär vid tidpunkter före och efter lågdosstrålbehandling: före LDRT (dag 0), slutet av första omgången av LDRT (sista dagen av LDRT, vanligtvis vid 3 Gy), och 3 månader (dag 111) efter avslutad RT.
Detta schema upprepas om patienten får ytterligare en LDRT-omgång för återfallsbehandling.
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upp till 9 månader efter avslutad RT
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Change of health-related quality of life
Tidsram: 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
Tidsram: upp till 9 månader efter avslutad 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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upp till 9 månader efter avslutad RT
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Samarbetspartners och utredare
Utredare
- Huvudutredare: Oliver J Ott, MD, Department of Radiation Oncology, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg
- Huvudutredare: Udo S Gaipl, PhD, Department of Radiation Oncology, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- IMMO-LDRT01
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