Chronic Inflammatory DisorderIMMO-LDRT01NCT02653079
Immunophenotyping From Blood of Patients Suffering From Chronic Degenerating Joint Diseases and Receiving LDRT
An observational study of Chronic Inflammatory Disorder, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Inflammatory Disorder
- What is being tested?
- Blood Draw and Questionaire
- How many people
- 250 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2016to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Show all 9Show fewer
- arthritis (gon- and anklearthrosis)
- Planned local low dose radiation therapy (LDRT) at the Department of Radiation Oncology, Universitätsklinikum Erlangen.
- Age at least 18 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Department of Radiation Oncology, Universitätsklinikum Erlangen
Erlangen, Bavaria, 91054
Benjamin Frey, PhD, +49 91 31 85 44248, benjamin.frey@uk-erlangen.de
Marga Lang-Welzenbach, M.A., +49 91 31 85 33968, st-studiensekretariat@uk-erlangen.de
About this study
Official title: Immunophenotyping From Blood of Patients Suffering From Chronic Degenerating Joint Diseases and Receiving Local Low Dose Radiation Therapy (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.
Read more
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
- Chronic Inflammatory Disorder
- Being tested
- Blood Draw and Questionaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Draw and QuestionaireOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Blood Draw and Questionaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of circulating immune cells of treated patients by deep immunophenotyping.
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.
Measured: up to 3 month after completion of RT
Secondary outcomes (4)
Change of joint pain intensity of the treated patients.
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.
Measured: up to 9 month after completion of RT
Change of functional capacity in daily life of the treated patients
Analysis of the functional capacity in daily life by FFbH-R (Funktionsfragebogen Hannover, 100% normal to 10 % nearly complete restricted) 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.
Measured: up to 9 month after completion of RT
Change of health-related quality of life
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.
Measured: up to 9 month after completion of RT
description of pain quality
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.
Measured: up to 9 month after completion of RT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2016 (estimated)
- Study startJun 2016
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Inflammatory DisorderStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Oliver J Ott, MD, Principal investigator, Department of Radiation Oncology, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-NürnbergUdo S Gaipl, PhD, Principal investigator, Department of Radiation Oncology, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02653079
- Sponsor's protocol ID
- IMMO-LDRT01
- Acronym
- IMMO-LDRT01
- Status last verified
- Feb 2023
- First submitted
- 8 Jan 2016
- Last updated
- 16 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Donaubauer AJ, Becker I, Weissmann T, Frohlich BM, Munoz LE, Gryc T, Denzler M, Ott OJ, Fietkau R, Gaipl US, Frey B. Low Dose Radiation Therapy Induces Long-Lasting Reduction of Pain and Immune Modulations in the Peripheral Blood - Interim Analysis of the IMMO-LDRT01 Trial. Front Immunol. 2021 Oct 12;12:740742. doi: 10.3389/fimmu.2021.740742. eCollection 2021.
PubMed 34712229
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunophenotyping From Blood of Patients Suffering From Chronic Degenerating Joint Diseases and Receiving Local Low Dose Radiation Therapy (LDRT)
- ClinicalTrials.gov ID
- NCT02653079
- Acronym / sponsor ID
- IMMO-LDRT01 / IMMO-LDRT01
- Conditions
- Chronic Inflammatory Disorder
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 12 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Cohort | – | Other: Blood Draw and QuestionaireBlood 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (9 listed)
- Patients suffering and diagnosed for:
- painful shoulder syndrome (periarthritis humeroscapularis)
- painful elbow syndrome (Epicondylopathia humeri)
- benign achillodynia
- benign calcaneodynia
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood Draw and QuestionaireThe 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. | Other | Study Cohort |
Primary outcome
Change of circulating immune cells of treated patients by deep immunophenotyping.
Time frame: up to 3 month after completion of RT
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.
4 secondary outcomes
Change of joint pain intensity of the treated patients.
Time frame: up to 9 month after completion of RT
Change of functional capacity in daily life of the treated patients
Time frame: up to 9 month after completion of RT
Change of health-related quality of life
Time frame: up to 9 month after completion of RT
description of pain quality
Time frame: up to 9 month after completion of RT
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
- Derived from this study: PubMed 34712229Donaubauer AJ, Becker I, Weissmann T, Frohlich BM, Munoz LE, Gryc T, Denzler M, Ott OJ, Fietkau R, Gaipl US, Frey B. Low Dose Radiation Therapy Induces Long-Lasting Reduction of Pain and Immune Modulations in the Peripheral Blood - Interim Analysis of the IMMO-LDRT01 Trial. Front Immunol. 2021 Oct 12;12:740742. doi: 10.3389/fimmu.2021.740742. eCollection 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Oliver J Ott, MD principal investigator
Department of Radiation Oncology, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg
Udo S Gaipl, PhD principal investigator
Department of Radiation Oncology, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Inflammatory Disorder, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Benjamin Frey, PhD (+49 9131 85 44248, benjamin.frey@uk-erlangen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of circulating immune cells of treated patients by deep immunophenotyping. (time frame: up to 3 month after completion of RT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02653079, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2023.