microRNAs in Systemic Scleroderma (Dig-ScS)

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

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

Study Overview

• Status: Recruiting
• Conditions: Scleroderma, Systemic
• Intervention / Treatment: Procedure: additional biopsies

• Study Type: Observational
• Enrollment (Anticipated): 18

Contacts and Locations

• Study Contact: Name: nihal martis, ph; Phone Number: 334 92 03 58 24; Email: martis.n@chu-nice.fr

Study Locations

• France
  • Nice, France, 06000
    • Recruiting
    • Nice hospital
    • Contact: nihal martis, ph; Phone Number: 33 4 92 03 58 24; Email: martis.n@chu-nice.fr
    • Principal Investigator: nihal martis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

people needed esogastro-duodenal fibroscopy

Description

Patient 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

Control inclusion criteria:

• 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
• Subject affiliated to Social Security or a similar scheme
• Subjects accepting additional digestive biopsies

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
• Subject stating that he has not been fasting for at least 10 hours
• Subject reporting HIV or HCV status
• Subject who had an infectious episode or was treated with antibiotics during the 4 weeks prior to the visit
• Subject with a positive pregnancy test
• Subject with graft versus host disease, or who has received therapy involving hematopoietic stem cells
• Subject with a severe and/or chronic and/or recurrent pathology, in particular:
• A chronic inflammatory disease of the intestine (Crohn's disease, ulcerative colitis), epidermis (psoriasis, atopic dermatitis), joints (rheumatoid arthritis), nervous system (multiple sclerosis); except ScS.
• A neurodegenerative disease
• Diabetes mellitus
• Subject who has been diagnosed with cancer and has not been in remission for more than 5 years

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patients; recruitement of 9 patients	Procedure: additional biopsies; additional biopsies during a fibroscopy planned in the care
control; recruitement of 9 control person	Procedure: additional biopsies; additional biopsies during a fibroscopy planned in the care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
description of the profile of miR based expression on cytokinic treatments and stimuli.	fundamental research aimed at determining an expression profile of miR as a function of cytokinic treatments and stimuli. proteins (cytokins) study to describe the profil of miR	4 years

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 11, 2021
• Primary Completion (ANTICIPATED): December 1, 2023
• Study Completion (ANTICIPATED): December 1, 2024

Study Registration Dates

• First Submitted: October 25, 2019
• First Submitted That Met QC Criteria: October 30, 2019
• First Posted (ACTUAL): November 1, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 18, 2021
• Last Update Submitted That Met QC Criteria: March 16, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Connective Tissue Diseases; Scleroderma, Systemic; Scleroderma, Diffuse; Scleroderma, Localized
• Other Study ID Numbers: 19-AOI-07

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No