Actively Recruiting
Immunophenotyping From Blood of Patients Suffering From Chronic Degenerating Joint Diseases and Receiving LDRT
Led by University of Erlangen-Nürnberg Medical School · Updated on 2023-02-16
250
Participants Needed
1
Research Sites
547 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Immunophenotyping From Blood of Patients Suffering From Chronic Degenerating Joint Diseases and Receiving LDRT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with painful shoulder syndrome (periarthritis humeroscapularis)
- Patients diagnosed with painful elbow syndrome (Epicondylopathia humeri)
- Patients diagnosed with benign achillodynia
- Patients diagnosed with benign calcaneodynia
- Patients diagnosed with arthrosis (finger-, rhiz-, gon-, and anklearthrosis)
- Patients diagnosed with arthritis (gon- and anklearthrosis)
- Planned local low dose radiation therapy (LDRT) at the Department of Radiation Oncology, Universitätsklinikum Erlangen
- Age at least 18 years
You will not qualify if you...
- Patients who have had or currently have any malignant diseases
- Fertile patients who refuse to use effective contraception during study treatment
- Patients with persistent drug and/or alcohol abuse
- Patients unable or unwilling to follow the study protocol
- Patients currently under care
- Patients unable to speak German
AI-Screening
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Trial Site Locations
Total: 1 location
1
Department of Radiation Oncology, Universitätsklinikum Erlangen
Erlangen, Bavaria, Germany, 91054
Actively Recruiting
Research Team
B
Benjamin Frey, PhD
CONTACT
M
Marga Lang-Welzenbach, M.A.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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