NCT04148716 (Dig-ScS) is a clinical trial of additional biopsies in Scleroderma, Systemic, sponsored by Centre Hospitalier Universitaire de Nice.

Who is sponsoring NCT04148716?

NCT04148716 is sponsored by Centre Hospitalier Universitaire de Nice.

What drugs are being tested in NCT04148716?

Interventions in NCT04148716: additional biopsies.

What condition does NCT04148716 study?

NCT04148716 studies Scleroderma, Systemic.

Is NCT04148716 still recruiting?

NCT04148716 is currently completed. Last updated 27 June 2024.

Last reviewed 2024-06-27 · How we verify

NCT04148716: Dig-ScS

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

microRNAs in Systemic Scleroderma

Completed Last updated 27 June 2024

What this trial tests

trial testing additional biopsies in Scleroderma, Systemic in 11 participants. Completed in 22 December 2022.

Timeline

11 January 2021

Primary endpoint
22 December 2022

22 December 2022

Quick facts

Lead sponsor	Centre Hospitalier Universitaire de Nice
Status	Completed
Study type	OBSERVATIONAL
Enrollment	11
Start date	11 January 2021
Primary completion	22 December 2022
Estimated completion	22 December 2022
Sites	1 location across France

Drugs / interventions tested

additional biopsies

Conditions studied

Scleroderma, Systemic — all drugs for Scleroderma, Systemic →

Sponsor

Centre Hospitalier Universitaire de Nice

Who can join

Adults 18 to 75, any sex, with Scleroderma, Systemic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Systemic Sclerosis Association with Malignancy.
Lepri G, Catalano M, Bellando-Randone S, Pillozzi S, et al · · 2022 · cited 28× · PMID 36121543 · DOI 10.1007/s12016-022-08930-4
Biomarkers in skin autoimmunity-An update on localised scleroderma.
Hernández-Bustos A, Bolos B, Astakhova K. · · 2024 · cited 2× · PMID 38577035 · DOI 10.1002/ski2.335

Verify or expand the search:

Other trials of additional biopsies

Trials testing the same drug.

NCT03293381 — Electrogram-Guided Myocardial Advanced Phenotyping · terminated

Other recruiting trials for Scleroderma, Systemic

Currently open trials in the same condition.

NCT06256575 — Study of Diosmin for the Treatment of Digital Ulcers in Systemic Sclerosis · NA · recruiting
NCT06697561 — Development and Evaluation of an Evidence-based Education Program for People With Hand Dysfunction in Scleroderma · NA · active not recruiting
NCT05878717 — A Study of the Efficacy and Safety of Belimumab in Adults With Systemic Sclerosis Associated Interstitial Lung Disease · Phase 2, PHASE3 · recruiting
NCT07345052 — Western Sweden Systemic Sclerosis Project · recruiting

Other Centre Hospitalier Universitaire de Nice trials

Trials by the same sponsor.

NCT05897996 — Percutaneous Anastomosis Creation for Hemodialysis Access · NA · withdrawn
NCT07499869 — INNOVATIVE BENEFITS OF A 4D VIRTUAL SIMULATOR · NA · not yet recruiting
NCT07492251 — Upadacitinib in Adult Patients With Erosive Mucosal Lichen Planus and Lichen Planopilaris: a Prospective Multicenter Ran · Phase 2 · not yet recruiting
NCT07511608 — Development of a New Technique for Quantifying Mitochondrial DNA in Single Muscle Fibers · NA · not yet recruiting
NCT07582406 — Codesign, Physical Activity, and Seniors · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04148716 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Centre Hospitalier Universitaire de Nice
Last refreshed: 27 June 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04148716.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing