Evaluation of the Role of miR-1 in the Pathogenesis and as a Biomarker in Muscular Dystrophies and Congenital Myopathies (Dystro-miR1)

February 24, 2026 updated by: University Hospital, Clermont-Ferrand

The study aims to find out if a specific blood molecule called miR-1, can be used as a biomarker to track the health of patients with certain muscle diseases.

MicroRNAs (miRs) are small messengers that help control how cells grow and stay healthy. Some of these, like miR-1, are specifically found in muscles and the heart. Research shows that levels of miR-1 are often abnormal in people with muscle-wasting conditions, but more information are needed to understand how this relates to the severity of the disease.

The main goal is to compare the blood levels of miR-1 between four different groups at different ages and severities:

  1. Patients with Duchenne or Becker muscular dystrophy (DMD/DMB).
  2. Patients with Myotonic Dystrophy Type 1 (Steinert's disease).
  3. Patients with congenital myopathies.
  4. Healthy volunteers (control group). The main objective is to assess if miR-1 levels can accurately show how a muscular disease is progressing.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

104

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age: Participants must be older than 2 years of age
  • Consent: Participants (or their legal guardians) must provide free and informed consent,. For children, the consent is oral for those under 6 years old and written for those over 6,.
  • Social Security: Every participant must be affiliated with the French social security system.
  • Participants must have a diagnosed neuromuscular pathology : the eligible pathologies are Myotonic Dystrophy Type 1 (DM1 or Steinert's disease), Duchenne Muscular Dystrophy (DMD), Becker Muscular Dystrophy (DMB), or congenital myopathies or are healthy participants.

Exclusion Criteria:

  • Refusal to participate expressed by the subject or their parental authority.
  • Engaging in intense and unusual physical effort within 10 days before the blood draw.
  • Current use of any treatment with systemic, muscular, or cardiac effects that could interfere with the study's biological results.
  • Subjects or their legal guardians who are under tutelage, curatorship, deprived of liberty, or under judicial protection.
  • Women who are pregnant or breastfeeding.
  • The presence of an additional pathology that, in the judgment of the clinician, could interfere with the biological findings

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: study group
Diagnostic test: dosage of blood biomarker miR1
Patients and controls will be asked to provide blood samples to evaluate their blood level of miR1 biomarker on a unique time participation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
blood expression level of micro-RNA miR-1
Time Frame: at a unique time of enrollment
The main goal is to evaluate the interest of miR-1 as a blood biomarker for neuromuscular diseases, specifically muscular dystrophies and congenital myopathies.
at a unique time of enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demographic Correlations
Time Frame: at a unique time of enrollment
The study will analyze the correlation between blood expression levels of miR-1 and the age and sex of the participants
at a unique time of enrollment
Severity correlation
Time Frame: at a unique time of enrollment

the study will analyse the correlation between miR-1 levels and the clinical severity of the neuromuscular condition.

Severity of Myotonic Dystrophy Type 1 (DM1): miR-1 level relation to the severity of the condition, looking at:

  • The clinical phenotype (based on the age of disease onset).
  • The number of CTG nucleotide repeats in the DMPK gene,.

  • The presence of cardiac involvement,.

    • Severity of Duchenne and Becker Muscular Dystrophies (DMD/DMB): miR-1 levels based on:

  • The presence of cardiac involvement,
  • The loss of ambulation (whether the patient has lost the ability to walk)
at a unique time of enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Collaborators

iGreD, Université Clermont Auvergne

Investigators

  • Principal Investigator: Catherine Sarret, MD, PhD, Prof, CHU de Clermont-Ferrand

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 11, 2026

Primary Completion (Estimated)

March 1, 2029

Study Completion (Estimated)

March 1, 2029

Study Registration Dates

First Submitted

February 10, 2026

First Submitted That Met QC Criteria

February 10, 2026

First Posted (Actual)

February 17, 2026

Study Record Updates

Last Update Posted (Actual)

February 25, 2026

Last Update Submitted That Met QC Criteria

February 24, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RBHP 2025 SARRET (Dystro-miR1)
  • 2025-A01149-40 (Other Identifier: 2025-A01149-40)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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