Pathology Analysis of OPMD Patient Myotomies

March 19, 2019 updated by: Hillel Yaffe Medical Center
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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

10

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

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

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

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who suffer from oculopharyngeal muscular dystrophy (OPMD).

Description

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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Data will be collected within four years.
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.
Data will be collected within four years.

Collaborators and Investigators

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

Sponsor

Hillel Yaffe Medical Center

Investigators

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

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)

March 19, 2019

Primary Completion (ANTICIPATED)

March 1, 2023

Study Completion (ANTICIPATED)

March 1, 2023

Study Registration Dates

First Submitted

March 4, 2019

First Submitted That Met QC Criteria

March 12, 2019

First Posted (ACTUAL)

March 14, 2019

Study Record Updates

Last Update Posted (ACTUAL)

March 21, 2019

Last Update Submitted That Met QC Criteria

March 19, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0115-18-HYMC

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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