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Immunophenotyping From Blood of Patients Suffering From Chronic Degenerating Joint Diseases and Receiving LDRT (IMMO-LDRT01)

15. februar 2023 opdateret af: University of Erlangen-Nürnberg Medical School

Immunfænotypning fra blod fra patienter, der lider af kroniske degenererende ledsygdomme og modtager lokal lavdosisstrålebehandling (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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Forventet)

250

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kun etui
  • Tidsperspektiver: Fremadrettet

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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.
Andet: Blood Draw and Questionaire
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change of circulating immune cells of treated patients by deep immunophenotyping.
Tidsramme: 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.
up to 3 month after completion of RT

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change of joint pain intensity of the treated patients.
Tidsramme: up to 9 month after completion of RT
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.
up to 9 month after completion of RT
Change of functional capacity in daily life of the treated patients
Tidsramme: op til 9 måneder efter afslutning af RT
Analyse af den funktionelle kapacitet i dagligdagen med FFbH-R (Funktionsfragebogen Hannover, 100 % normal til 10 % næsten fuldstændig begrænset) spørgeskema på tidspunkter før og efter lavdosis strålebehandling: før LDRT (dag 0), slutningen af ​​første runde af LDRT (sidste dag af LDRT, normalt ved 3 Gy) og 3 måneder (dag 111) efter afsluttet RT. Dette skema gentages, hvis patienten modtager yderligere LDRT-runde til tilbagefaldsbehandling.
op til 9 måneder efter afslutning af RT
Change of health-related quality of life
Tidsramme: up to 9 month after completion of RT
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.
up to 9 month after completion of RT
description of pain quality
Tidsramme: up to 9 month after completion of RT
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.
up to 9 month after completion of RT

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Erlangen-Nürnberg Medical School

Efterforskere

  • Ledende efterforsker: Oliver J Ott, MD, Department of Radiation Oncology, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg
  • Ledende efterforsker: Udo S Gaipl, PhD, Department of Radiation Oncology, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juni 2016

Primær færdiggørelse (Forventet)

1. december 2025

Studieafslutning (Forventet)

1. december 2026

Datoer for studieregistrering

Først indsendt

8. januar 2016

Først indsendt, der opfyldte QC-kriterier

8. januar 2016

Først opslået (Skøn)

12. januar 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. februar 2023

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. februar 2023

Sidst verificeret

1. februar 2023

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IMMO-LDRT01

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