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

NCT05181930 | Completed

• 1 other identifier: 2017-A01555-48
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

"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. "

Conditions

Sarcoidosis

Keywords

Sarcoidosis; Urinary; NMR spectroscopy; Metabolomic

Outcome Measures

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

  NMR analysis on urine sample

  At inclusion

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a diagnosis of sarcoidosis according to ATS / ERS / WASOG criteria consulting at the Pulmonary Department of the Avicenne University Hospital

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hopital Avicenne,AP-HP

Bobigny, 93009, France

Location

Related Publications (1)

• Duchemann B, Triba MN, Guez D, Rzeznik M, Savarin P, Nunes H, Valeyre D, Bernaudin JF, Le Moyec L. Nuclear magnetic resonance spectroscopic analysis of salivary metabolome in sarcoidosis. Sarcoidosis Vasc Diffuse Lung Dis. 2016 Mar 29;33(1):10-6.

  PMID: 27055831 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urinary sample

MeSH Terms

Conditions

Sarcoidosis

Condition Hierarchy (Ancestors)

Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases

Study Officials

• Jean-François BERNAUDIN, MD PhD

  APHP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2021
• First Posted: January 10, 2022
• Study Start: January 30, 2018
• Primary Completion: October 16, 2019
• Study Completion: June 1, 2021
• Last Updated: May 8, 2023

Record last verified: 2021-09

Locations

FR (1)