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Pathology Analysis of OPMD Patient Myotomies

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ClinicalTrials.gov Identifier: NCT03874910
Recruitment Status : Recruiting
First Posted : March 14, 2019
Last Update Posted : March 21, 2019
Sponsor:
Information provided by (Responsible Party):
Hillel Yaffe Medical Center

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
Oculopharyngeal Muscular Dystrophy

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





Primary Outcome Measures :
  1. Number of genes that show changes in RNA profile, measured by sequencing. [ Time Frame: 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. [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who suffer from oculopharyngeal muscular dystrophy (OPMD).
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03874910


Contacts
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Contact: Itzhak Braverman, Doctor (MD) +972-4-6304549 ext +97246304549 braverman@hy.health.gov.il

Locations
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Israel
Hillel Yaffe Medical Center Recruiting
Hadera, Israel
Contact: Ilana Alony, Mrs    +972-52-3747719 ext +97246304549    IlanaA@hy.health.gov.il   
Principal Investigator: Itzhak Braverman, Doctor (MD)         
Sponsors and Collaborators
Hillel Yaffe Medical Center
Investigators
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Principal Investigator: Itzhak Braverman, Doctor (MD) Hillel Yaffe Medical Center, Israel

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Responsible Party: Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT03874910     History of Changes
Other Study ID Numbers: 0115-18-HYMC
First Posted: March 14, 2019    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Muscular Dystrophies
Muscular Dystrophy, Oculopharyngeal
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Genetic Diseases, Inborn