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Longitudinal Biomarkers With Selected Outcome Measures In CMT

Study acronym: CMT-BIO-Extend
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated March 9, 2026 (before its estimated July 5, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Primary completion date: May 5, 2025 to Jul 5, 2026 Completion date: Aug 5, 2025 to Jul 5, 2026 · Study description shortened, about 26 wordsv2 Show 2 more changesShow less
    • Completion date: Aug 5, 2025 to Jul 5, 2026
    • Study description shortened, about 26 words

    See this version in full on ClinicalTrials.gov ↗

  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this study is to better understand the progression of CMT1A and identify risk factors influencing disease course. CMT1A, the most common hereditary peripheral neuropathy, shows high variability in individual phenotypes despite genetic similarity. Key objectives include analyzing determinants of phenotypic expression and documenting symptom variability over five years to capture disease dynamics. Although incurable, novel CMT therapies are in development. Proving efficacy is challenging due to slow progression and limited sensitive outcome measures. This study aims to validate biomarkers (DNA/epigenetics and RNA/RT-PCR) and sensitive outcome measures from blood and skin of CMT patients over five years to support clinical therapy trials. Approximately 25 healthy volunteers will serve as controls, providing blood and skin samples for biomarker validation. Additionally, the project will build a tissue collection (skin, blood, and cultured fibroblasts) from CMT patients of various subtypes for unrestricted scientific research, especially for the German CMT-NET network (NCT03386266). Scientific partners have free access to samples and data for research (commercial use is excluded). Currently, this collection includes over 100 standardized skin biopsies from CMT1A patients and is Germany's only repository for hereditary neuropathy tissue samples.
Trial Details
NCT Number NCT06794489
Lead Sponsor University Medical Center Goettingen
Conditions CMT1A, CMT (Charcot Marie Tooth Disease), CMT 1A, CMT - Charcot-Marie-Tooth Disease
Enrollment 75 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov