NCT02653079 Immunophenotyping From Blood of Patients Suffering From Chronic Degenerating Joint Diseases and Receiving LDRT
| NCT ID | NCT02653079 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Erlangen-Nürnberg Medical School |
| Condition | Chronic Inflammatory Disorder |
| Study Type | OBSERVATIONAL |
| Enrollment | 250 participants |
| Start Date | 2016-06 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 250 participants in total. It began in 2016-06 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Oliver J Ott, MD
PRINCIPAL INVESTIGATOR
Department of Radiation Oncology, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg
Frequently Asked Questions
Who can join the NCT02653079 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Inflammatory Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02653079 currently recruiting?
Yes, NCT02653079 is actively recruiting participants. Contact the research team at benjamin.frey@uk-erlangen.de for enrollment information.
Where is the NCT02653079 trial being conducted?
This trial is being conducted at Erlangen, Germany.
Who is sponsoring the NCT02653079 clinical trial?
NCT02653079 is sponsored by University of Erlangen-Nürnberg Medical School. The principal investigator is Oliver J Ott, MD at Department of Radiation Oncology, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg. The trial plans to enroll 250 participants.