microRNAs in Systemic Scleroderma (Dig-ScS)

Centre Hospitalier Universitaire de Nice

Status

Completed

Conditions

Scleroderma, Systemic

Treatments

Procedure: additional biopsies

Study type

Observational

Funder types

Other

Identifiers

NCT04148716

19-AOI-07

Details and patient eligibility

About

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

Enrollment

11 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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