SarcoidosisRMN-SARCURINESNCT05181930
Nuclear Magnetic Resonance Spectroscopic Analysis of Urinary Metabolome in Sarcoidosis (RMN-SARCURINES)
An observational study of Sarcoidosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sarcoidosis
- How many people
- 42 participants
- Where
- 1 siteFrance
- Study dates
- 30 Jan 2018to 1 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a diagnosis of sarcoidosis according to ATS / ERS / WASOG criteria consulting at the Pulmonary Department of the Avicenne University Hospital
Who may be able to join
- Patients with a diagnosis of sarcoidosis according to ATS / ERS / WASOG criteria.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nuclear Magnetic Resonance Spectroscopic Analysis of Urinary Metabolome in Sarcoidosis
"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. "
Read the detailed 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. "
- Conditions
- Sarcoidosis
- Keywords
- Sarcoidosis, Urinary, NMR spectroscopy, Metabolomic
- Medical subject headings
- Sarcoidosis
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2022
- Study start30 Jan 2018
- Primary completion16 Oct 2019
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SarcoidosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-François BERNAUDIN, MD PhD, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05181930
- Sponsor's protocol ID
- 2017-A01555-48
- Acronym
- RMN-SARCURINES
- Status last verified
- Sep 2021
- First submitted
- 20 Dec 2021
- Last updated
- 8 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 27055831
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nuclear Magnetic Resonance Spectroscopic Analysis of Urinary Metabolome in Sarcoidosis
- ClinicalTrials.gov ID
- NCT05181930
- Acronym / sponsor ID
- RMN-SARCURINES / 2017-A01555-48
- Conditions
- Sarcoidosis
- Keywords
- Sarcoidosis, Urinary, NMR spectroscopy, Metabolomic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 30 Jan 2018 (actual)
- Primary completion
- 16 Oct 2019 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 10 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
"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. "
Detailed 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. "
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a diagnosis of sarcoidosis according to ATS / ERS / WASOG criteria consulting at the Pulmonary Department of the Avicenne University Hospital
Key inclusion criteria (1 listed)
- Patients with a diagnosis of sarcoidosis according to ATS / ERS / WASOG criteria.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2023.
- Background: PubMed 27055831Duchemann 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-François BERNAUDIN, MD PhD principal investigator
APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcoidosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05181930, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2023.