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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05181930
Other study ID # 2017-A01555-48
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 30, 2018
Est. completion date June 1, 2021

Study information

Verified date September 2021
Source Assistance Publique - Hôpitaux de Paris
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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. "


Description:

"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. "


Recruitment information / eligibility

Status Completed
Enrollment 42
Est. completion date June 1, 2021
Est. primary completion date October 16, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Hopital Avicenne,AP-HP Bobigny

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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