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Not yet recruiting NCT06312774

Feasibility of Proteomics in Chronic Lung Disease With Sarcopenia

Observational Sarcopenia Chronic Lung Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: This is observational study.
Who it may be relevant to
Registry conditions: Sarcopenia, Chronic Lung Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Feasibility Study for Comparative Analysis of Proteome and Single-cell RNA Sequencing in Chronic Lung Disease Patients With and Without Sarcopenia

Overview

Sarcopenia, the loss of muscle mass and strength with ageing, is a prevalent condition in older adults, particularly those with chronic lung diseases like COPD and interstitial lung disease. The condition exacerbates the decline in physical ability, leading to decreased mobility, impaired quality of life, and increased disability. Sarcopenia's prevalence varies across populations, estimated to affect up to 10% of adults over 60 worldwide, with higher rates reported in studies employing consensus definitions of sarcopenia. The prevalence is even higher in patients with chronic lung diseases, reaching up to 26.6%. Sarcopenia's impact on health-related quality of life has been widely investigated. The condition is associated with various comorbidities, including chronic heart failure, obesity, diabetes, and chronic kidney disease, all negatively impacting the quality of life. The proposed study's primary aim is to assess the feasibility of the FACS (finding, assessing, confirming, severity) approach in determining sarcopenia's prevalence in the chronic lung disease population. FACS includes screening, strength measurements, and bioelectrical impedance analysis (BIA) to confirm sarcopenia. The study will also explore potential mechanisms associated with sarcopenia in this population, using proteome and single-cell transcriptome profiles. These multi-omics approaches provide a comprehensive view of the cellular and molecular changes underlying sarcopenia.In particular, the study will evaluate patient acceptance, time efficiency of each test, and recruitment effectiveness. The outcomes will guide the design and execution of subsequent, larger studies and provide preliminary data for power calculation for the full-scale study.

Interventions

  • Other This is observational study
    This is observational study

Primary outcome measures

  • Sarcopenia [Time frame: 3 years]

Eligibility criteria

Inclusion criteria

  • Adult patients diagnosed with chronic lung disease (≥ 18years).
  • Only patients who are willing and able to provide informed consent to participate in the study.

Exclusion criteria

  • Patients with other major comorbidities that could significantly impact muscle mass and function, such as severe heart failure, advanced liver or kidney disease, uncontrolled diabetes, or malignancies.
  • Patients with acute exacerbations of their chronic lung disease or any other acute illness at the time of the study. 3. Patients with a history of neuromuscular disorders or disability that could significantly affect muscle mass and function.

4\. Patients who have undergone recent surgery in the past 6 months or have received specific treatments that could influence muscle mass and function, such as long-term corticosteroid use, chemotherapy, or radiation therapy.

5\. Patients with life expectancy of less than 6 months 6. Patients who are unable or unwilling to comply with the study protocol or procedures.

7\. Patients that are unable to give informed consent.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06312774 · IRAS 333853

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗