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microRNAs in Systemic Scleroderma | Clinical Trials | Clareo Health

COMPLETED

microRNAs in Systemic Scleroderma

Identification and Characterization of microRNAs Involved in Esophageal, Gastric and Duodenal Fibrotic Manifestations of Systemic Scleroderma

NCT04148716•Centre Hospitalier Universitaire de Nice

View on ClinicalTrials.gov

Summary

No studies have investigated the expression of miRNAs in Dig-ScS tissues. In the absence of specific treatment for this frequent impairment in this connectivity, the team proposes to study miRNA profiles in the esophagus and duodenum to identify new therapeutic targets. The team is studying the involvement of pro-fibrotic "key" miRNAs called "FibromiRs", including 3 miRNAs from the DNM3os locus (miR-199a-3p, miR-199a-5p and miR-214 - characterized by the host laboratory) associated with monitoring the response to TGF-β in fibroblasts and their potential interaction with pharmacological treatments such as nintedanib and/or PPARγ agonists. The approach is part of a pilot study that can lead to a larger project after validation of the hypotheses. It also seems interesting to make a precise anatomopathological description with a gradation of the digestive fibrotic damage in view of the paucity of medical literature in this field

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subject aged between 18 and 75 years old, meeting the 2013 ACR/EULAR classification criteria for ScS
•Subject under an indication for the performance of esogastro-duodenal fibroscopy (FOGD), the main ones being: anemia, anorexia, weight loss, gastroesophageal reflux disease, dysphagia or odynophagia, ulcer syndrome, suspected portal hypertension
•Supported at Nice University Hospital
•Subject understands and speaks French and is able to give written consent
•Subject affiliated to Social Security or a similar scheme
•Subjects accepting additional digestive biopsies
•Subject aged between 18 and 75 years old, without dysimmunitary disease
•Subject within the scope of an indication for the performance of a FOGD as defined by the treating gastroenterologist
•Subject accepting to be serologically tested for HIV and HCV
•Subject understands and speaks French and is able to give written consent
+2 more criteria

Exclusion Criteria

•Subject protected by law under guardianship or curatorship, or unable to participate in a clinical study under Article L. 1121-16 of the French Public Health Code
•Subject who has participated in a clinical research study in the last 3 months in which he/she was exposed to a pharmaceutical product or medical device
•Subject who has stayed in a tropical or subtropical country in the last 3 months
•Pregnant or breastfeeding participant
•Subject on a special diet for medical reasons and prescribed by a doctor or dietician (e.g. a low-calorie diet or a diet designed to lower cholesterol levels)
•Subject who regularly consumes large quantities of alcohol, i. e. more than 50 g of pure alcohol per day (e. g. more than 4 glasses of 150 ml wine, more than 4 pints of 250 ml beer, or more than 4 glasses of 40 ml containing strong alcohol)
•Subject who has used an illegal recreational drug in the past 3 months
•Subject who has taken an immunosuppressive or immunomodulatory drug (excluding corticosteroids administered at doses ≤ 10 mg/d PREDNISONE equivalent) within the previous 2 weeks, or for more than 14 consecutive days within the last 3 months
•Subject who has been vaccinated within the last 3 months
•Subject who received a blood transfusion or immunoglobulins in the last 3 months
+10 more criteria

Locations (1)

Nice Hospital

Nice, France

Key Dates

Start Date

January 11, 2021

Primary Completion Date

December 22, 2022

Completion Date

December 22, 2022

Last Updated

June 27, 2024

Enrollment

ACTUAL participants

Conditions

Scleroderma, Systemic

Interventions

additional biopsies

PROCEDURE

A Study of the Efficacy and Safety of Belimumab in Adults With Systemic Sclerosis Associated Interstitial Lung Disease

NCT05878717

Systemic Sclerosis Associated Interstitial Lung DiseaseScleroderma, Systemic

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RECRUITING

Pilot Study of Description of Cicatrisation Rates of Digital Ulcers in Systemic Scleroderma

NCT04319120

Scleroderma, Systemic

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 27, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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microRNAs in Systemic Scleroderma

Inclusion Criteria

Exclusion Criteria

A Study of the Efficacy and Safety of Belimumab in Adults With Systemic Sclerosis Associated Interstitial Lung Disease

Pilot Study of Description of Cicatrisation Rates of Digital Ulcers in Systemic Scleroderma

Development and Evaluation of an Evidence-based Education Program for People With Hand Dysfunction in Scleroderma

Profibrosing Role of B Lymphocytes in Patients With Systemic Sclerosis.

Study of Gynecological Follow-up of Patients With Autoimmune Disease or Inflammatory Rheumatism

Exercise With Scleroderma Functional Outcomes