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Pathology Analysis of OPMD Patient Myotomies

Sponsor
Hillel Yaffe Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT03874910
Collaborator
(none)
10
Enrollment
1
Location
47.4
Anticipated Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study aims to characterize the effect of OPMD mutation on muscle function. Muscle samples will be received from oculopharyngeal muscular dystrophy (OPMD) patients who undergo cricopharyngeal muscle-cutting surgery, as part of their routine healthcare and treatment.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    10 participants
    Observational Model:
    Other
    Time Perspective:
    Cross-Sectional
    Official Title:
    Pathology Analysis of OPMD Patient Myotomies
    Actual Study Start Date :
    Mar 19, 2019
    Anticipated Primary Completion Date :
    Mar 1, 2023
    Anticipated Study Completion Date :
    Mar 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Number of genes that show changes in RNA profile, measured by sequencing. [Data will be collected within four years.]

      RNA profile analysis of OPMD muscle samples will be compared to unaffected muscle samples using sequencing to identify gene numbers.

    2. Number of genes that show changes in protein profile, measured by SDS page. [Data will be collected within four years.]

      Protein profile analysis of OPMD muscle samples will be compared to unaffected muscle samples to identify gene numbers using SDS page.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • OPMD patients both male and female.

    • OPMD patients between the ages 18-70 years.

    • OPMD patients who are referred to the cricopharyngeal muscle-cutting surgery as part of their usual treatment.

    Exclusion Criteria:

    • OPMD patients not referred to the cricopharyngeal muscle-cutting surgery as part of their usual treatment.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hillel Yaffe Medical Center Hadera Israel

    Sponsors and Collaborators

    • Hillel Yaffe Medical Center

    Investigators

    • Principal Investigator: Itzhak Braverman, Doctor (MD), Hillel Yaffe Medical Center, Israel

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hillel Yaffe Medical Center
    ClinicalTrials.gov Identifier:
    NCT03874910
    Other Study ID Numbers:
    • 0115-18-HYMC
    First Posted:
    Mar 14, 2019
    Last Update Posted:
    Mar 21, 2019
    Last Verified:
    Mar 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Muscular Dystrophies
    Muscular Dystrophy, Oculopharyngeal

    Study Results

    No Results Posted as of Mar 21, 2019