RecruitingNCT06696027

AYLo - AutoimmunitY and Loss of y

Investigating the Role of Hematopoietic Mutations and Mosaic Mutation in the Y Chromosome in Autoimmune Rheumatologic Diseases


Sponsor

University of Bonn

Enrollment

500 participants

Start Date

Nov 15, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

The AYLo study (AutoimmunitY and Loss of y - Investigating the Role of Hematopoietic Mutations and Mosaic Mutation in the Y Chromosome in Autoimmune Rheumatologic Diseases) aims to systematically investigate hematopoietic mutations, such as hematopoietic (mosaic) loss of the Y chromosome (mLOY), focusing on their underlying causes, pathophysiological significance, patterns of manifestation, and impact on disease progression in autoimmune, rheumatologic disorders. This research seeks to bridge existing knowledge gaps by exploring how such mutations influence immune homeostasis, cellular function, and susceptibility to inflammation-driven pathologies. Through the integration of advanced immunological profiling, the study aspires to uncover key mechanisms that drive the initiation, progression, and complications of autoimmune rheumatic diseases. These analyses will combine single nucleotide polymorphisms (SNP) arrays, multiplex assays, transcriptomics, and flow cytometry staining of peripheral blood mononuclear cells to delineate the interplay between hematopoietic mutations and immune dysregulation. A further objective is the development of a multimodal framework for disease-specific characterization, enabling precise mapping of mutation-driven phenotypes across diverse autoimmune conditions. This framework will incorporate clinical, molecular, and imaging data. Additionally, the AYLo study aims to explore the potential role of mLOY and other hematopoietic mutations as biomarkers for disease stratification, prognosis, and therapeutic response. The findings may open avenues for personalized treatment approaches, leveraging the molecular insights to inform targeted interventions and improve patient outcomes in autoimmune rheumatic disorders. By integrating translational and basic science approaches, this study has the potential to redefine current paradigms in autoimmune disease research and therapy.


Eligibility

Sex: MALEMin Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether the loss of the Y chromosome in immune cells — a natural phenomenon that increases with age in men — is associated with a higher risk of developing autoimmune and inflammatory diseases such as rheumatoid arthritis, lupus, COPD, and others. Researchers will compare Y chromosome loss in men with these conditions versus healthy men. **You may be eligible if...** - You are male and over 50 years old - You have been diagnosed by your doctor with one of the following: rheumatoid arthritis, psoriatic arthritis, lupus, systemic sclerosis, Sjögren's syndrome, vasculitis, sarcoidosis, COPD, interstitial lung disease, or asthma - OR you are a healthy male over 50 with no autoimmune or lung condition (for the control group) **You may NOT be eligible if...** - You are female - You are under 50 years old - You are a healthy man with a history of autoimmune or pulmonary disease (for the control group) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DIAGNOSTIC_TESTSingle nucleotide polymorphisms (SNP)

Utilizing single nucleotide polymorphisms (SNP) genotyping mosaic loss of y (mLOY) of individual patient will be assessed.

DIAGNOSTIC_TEST3'mRNA sequencing

3'mRNA sequencing analyzes gene expression profiles related to the immune response in different study cohorts, aiding in understanding the genetic underpinnings of inflammation and its association with mLOY.

DIAGNOSTIC_TESTEnzyme-linked immunosorbent assay (ELISA) and Legendplex Array

Used to measure cytokine levels in the serum of investigated patients, aiding in profiling inflammatory markers that are indicative of disease activity, response to treatment and consequence of mLOY..

DIAGNOSTIC_TESTFlow Cytometry

Employed to analyze immune cell phenotypes in investigated cohorts. This test helps identify various immune cell subsets and their activation states, which are critical for understanding disease mechanisms and its association with mLOY.

DIAGNOSTIC_TESTLaboratory assessment

Serum Chemistry

DIAGNOSTIC_TESTAssessment of Pulmonary Involvement

Results of routine clinical assessment of pulmonary involvement (such as lung ultrasound, computed tomography, chest x-ray, whole-body plethysmography) will be compared to mLOY, ELISA/ Legendplex/ flow cytometry/ transcriptome analysis results.


Locations(1)

Department of Rheumatology

Bonn, North Rhine-Westphalia, Germany

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06696027


Related Trials