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Completed

NCT Number: NCT05181930

Nuclear Magnetic Resonance Spectroscopic Analysis of Urinary Metabolome in Sarcoidosis (RMN-SARCURINES)

"Sarcoidosis is a systemic granulomatous disease of unknown cause(s).Determining disease activity is a major element in the treatment decision.

1H- Nuclear magnetic resonance (NMR) spectroscopy allows the identification of biomarkers in different pathologies and in particular in a pilot study of saliva of patients with sarcoidosis. Applications to sarcoidosis are still rare, having concerned only serum and saliva. In this context we hypothesize the existence of a difference in the metabolic products found in the urine of sarcoidosis patients with different degrees of activity and/or disease severity.

We designed an analysis of urinary metabolomics in sarcoidosis patient using NMR spectroscopy with multivariate statistical analysis, followed by metabolite identification and pathway analysis. "

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hopital Avicenne,AP-HP

Bobigny, 93009, France

About this study

"Sarcoidosis is a systemic granulomatous disease of unknown cause(s) with an almost constant lung involvement. Clinical expression varies greatly in both evolution and severity. The activity of the disease is currently based on serum markers (elevation of angiotensin-converting enzyme) with poor sensitivity/specificity or on imaging techniques (18F-FDG PET-CT) which are more invasive and more expensive. Determining disease activity is a major element in the treatment decision.

The spectra of small molecules resulting from metabolism (metabolome/metabolomics) evaluated by spectrometry in different biological fluids (blood, saliva, urine) during different physiological or pathological conditions have been identified as promising biomarkers. 1H- Nuclear magnetic resonance (NMR) spectrometry allows the identification of biomarkers in different pathologies and in particular in a pilot study of saliva of patients with sarcoidosis. Applications to sarcoidosis are still rare having concerned only serum and saliva. The application of this method to the urinary metabolome has shown its effectiveness in other situations, for example in celiac disease.

In this context we hypothesize the existence of a difference in the metabolic products found in the urine of sarcoidosis patients with different degrees of activity and/or disease severity.

We designed an analysis of urinary metabolomics in sarcoidosis patient using NMR spectroscopy with multivariate statistical analysis, followed by metabolite identification and pathway analysis. "

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with a diagnosis of sarcoidosis according to ATS / ERS / WASOG criteria.

Exclusion criteria

  • Treatment (corticosteroids, plaquenil, immunosuppressants) within the last 6 months
  • Patients with diabetes.
  • Patient with long-term or recent drug treatment (e.g. antibiotics)
  • Patients with a urinary tract infection or urinary lithiasis at the time of collection.
  • Renal failure

Treatment and study plan

Primary outcomes

  1. Qualitative and quantitative analysis of NMR spectra of urine samples from a population of patients with sarcoidosis and comparison with an overall disease activity score

    Time frame: At inclusion

    NMR analysis on urine sample

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Nuclear Magnetic Resonance Spectroscopic Analysis of Urinary Metabolome in Sarcoidosis

Acronym: RMN-SARCURINES

Important dates

Study start
2018
Primary completion
2019
Study completion
2021
First posted
Jan 10, 2022
Registry last updated
May 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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