MDTRP Neuromuscular Research Biobank

Neuromuscular Diseases Clinical Trial

— NRB-0001  

Official title:

Muscular Dystrophy Translational Research Program Neuromuscular Research Biobank

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05434572
• Other study ID #: HM20021172
• Status: Recruiting
• Start date: March 17, 2021
• Est. completion date: February 2030

Study information

• Verified date: June 2023
• Source: Virginia Commonwealth University
• Contact: Nicholas Johnson
• Phone: 804-628-1624
• Email: nicholas.johnson[@]vcuhealth.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The purpose of this research repository is to collect, store, and share with other researchers any tissues that subjects with all types of neuromuscular disease are willing to donate. These samples will be stored at Virginia Commonwealth University (VCU) and will be used for future research with this population.

Description:

The study involves collection of medical information about research participants and their families. No identifying information about family members will be collected. Research participants will be asked for any general knowledge they have related to possible neurological disorders. Research participants are also given the opportunity to provide blood, skin cells, urine, saliva, fecal matter, muscle tissue, cells, DNA and/or RNA samples. Before any study procedures take place, the informed consent form will be provided and reviewed with potential research participants in detail. Potential research participants will have an opportunity to ask additional questions before starting any study procedures.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: February 2030
• Est. primary completion date: January 2030
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 75 Years

Eligibility

Inclusion Criteria:

• Willing and able to give informed consent
• Positive diagnosis or suspected diagnosis of neuromuscular disease, or
• Family history of neuromuscular disease, or
• Healthy volunteer
• Age Neonates-75

Exclusion Criteria:

• Unwilling to sign consent

Related Conditions & MeSH terms

• Neuromuscular Diseases
• Neuromuscular Diseases in Children
• Neuromuscular Disorder

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To collect, store, and share with other researchers any tissues that subjects with all types of neuromuscular disease are willing to donate.	Subjects will have the opportunity to provide the following samples: saliva or cheek swab, urine sample (up to 15ml), feces (up to 2mg of a stool sample), blood (up to 40ml), muscle biopsy tissue, and cell line (subjects have the option to allow a cell line to be made from their blood, muscle, or skin biopsies to provide a renewable supply of DNA and other cell components for research)	Baseline
Secondary	To collect medical history information from subjects with all types of neuromuscular disease and healthy controls.	Information will be collected from the subject medical records and will include care they have received in the past, are receiving now, or may receive in the future. Subject information may include name, age, gender, diagnosis, and other medical history information that may be beneficial to the research staff.	Baseline