Identification and Characterization of microRNAs Involved in Esophageal, Gastric and Duodenal Fibrotic Manifestations of Systemic Scleroderma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- description of the profile of miR based expression on cytokinic treatments and stimuli.
研究概览
简要总结
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
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •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
结局指标
主要结局
description of the profile of miR based expression on cytokinic treatments and stimuli.
时间窗: 4 years
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
次要结局
未报告次要终点