Actively Recruiting

Age: 18Years +
All Genders
NCT02653079

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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Immunophenotyping From Blood of Patients Suffering From Chronic Degenerating Joint Diseases and Receiving LDRT | DecenTrialz