CIMR Neuromuscular Research Biobank

Recruiting

• Conditions: Neuromuscular Disorder; Neuromuscular Diseases in Children; Neuromuscular Diseases

• Registration Number: NCT05434572
• Lead Sponsor: Virginia Commonwealth University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2021-03-17
• Study First Submitted: 2022-06-21
• Study First Submitted QC: 2022-06-21
• Study First Posted: 2022-06-28
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-28
• Last Update Posted: 2024-07-03
• Primary Completion: 2030-01
• Study Completion: 2030-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To collect, store, and share with other researchers any tissues that subjects with all types of neuromuscular disease are willing to donate.	Baseline	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)

Secondary Outcome Measures

Name	Time	Method
To collect medical history information from subjects with all types of neuromuscular disease and healthy controls.	Baseline	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.

Trial Locations

Locations (1)

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States