RECRUITING

A Natural History Study of RYR1-Related Disorders

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Background: Congenital myopathies (CM) are genetic disorders that can cause decreased muscle tone and muscle weakness. Most CMs in the United States are related to the ryanodine receptor 1 (RYR1) gene. Researchers need more natural history data to learn about these CMs in children and adults. Objective: To learn more about the signs, symptoms, and course of RYR1-related disorders. Eligibility: People aged 7 years and older with an RYR1-related disorder. Design: Ambulatory participants will come to the Clinical Center and non-ambulatory participants will visit via telehealth. Visits will be once a year for 3 or 5 years. Clinical Center visits will take 2 to 3 days. All participants will undergo tests including: Photos and videos. These will be taken to document the participant s condition. Blood and urine tests. Activity Tracker. Participants will wear a device to record their activity. Questionnaires. Participants will answer questions about their health, pain, fatigue, stress, quality of life, and other topics. Participants who visit the Clinical Center will also undergo: Tests of heart and lung function. Motor skills and strength tests. Participants will walk, climb stairs, kneel, crawl, stand up, and perform other movements to test their strength and abilities. They will squeeze and pinch a handheld device to test their grip. Imaging scans. Skin biopsy. Adult participants may opt to have a sample of skin taken (one time only). Eye exam

Official Title

A Single-Center Prospective Natural History Study of RYR1-Related Disorders

Quick Facts

Study Start:2025-02-23
Study Completion:2031-12-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06287762

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.

Ages Eligible for Study:7 Years to 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Irene C Chrismer, R.N.
CONTACT
(240) 591-8884
irene.chrismer@nih.gov
Tokunbor A Lawal, C.R.N.P.
CONTACT
(301) 451-5951
lawalt@mail.nih.gov

Principal Investigator

Tokunbor A Lawal, C.R.N.P.
PRINCIPAL_INVESTIGATOR
National Institute of Nursing Research (NINR)

Study Locations (Sites)

National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
United States

Collaborators and Investigators

Sponsor: National Institute of Nursing Research (NINR)

  • Tokunbor A Lawal, C.R.N.P., PRINCIPAL_INVESTIGATOR, National Institute of Nursing Research (NINR)

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 Registration Dates

Study Start Date2025-02-23
Study Completion Date2031-12-30

Study Record Updates

Study Start Date2025-02-23
Study Completion Date2031-12-30

Terms related to this study

Keywords Provided by Researchers

  • RYR1
  • Muscle Disease
  • Natural History
  • Congenital Myopathy

Additional Relevant MeSH Terms

  • Ryanodine Receptor 1-Related Myopathy
  • Ryanodine Receptor 1 Related Disorders