Pathology Analysis of OPMD Patient Myotomies

Oculopharyngeal Muscular Dystrophy Clinical Trial

Official title:

Pathology Analysis of OPMD Patient Myotomies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03874910
• Other study ID #: 0115-18-HYMC
• Status: Recruiting
• Start date: March 19, 2019
• Est. completion date: March 2023

Study information

• Verified date: March 2019
• Source: Hillel Yaffe Medical Center
• Contact: Itzhak Braverman, Doctor (MD)
• Phone: +972-4-6304549
• Email: braverman[@]hy.health.gov.il
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: March 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Muscular Dystrophies
• Muscular Dystrophy, Oculopharyngeal
• Oculopharyngeal Muscular Dystrophy

Locations

Country	Name	City	State
Israel	Hillel Yaffe Medical Center	Hadera

Sponsors (1)

Lead Sponsor	Collaborator
Hillel Yaffe Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of genes that show changes in RNA profile, measured by sequencing.	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.
Primary	Number of genes that show changes in protein profile, measured by SDS page.	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.