RECRUITING

Cardiopulmonary Outcomes in Osteogenesis Imperfecta: BBD7708

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

Osteogenesis imperfecta (OI) is a group of congenital and heritable bone disorders that currently affects at least 50,000 people in the United States. OI varies in severity from perinatally lethal to mild forms. The majority of cases is caused by a dominant mutation in type I collagen genes (COL1α1 and COL1α2), altering the quantity or quality of type I collagen. Although OI is typically characterized as a disease of the bone, it is perhaps more accurately described as a connective tissue disorder. Type I collagen is a major constituent of lung connective tissue. Respiratory insufficiency is the leading cause of death in patients with OI. Thus, it is important and necessary to understand the etiology of the restrictive pulmonary physiology in the OI population.

Official Title

Cardiopulmonary Outcomes in Osteogenesis Imperfecta: BBD7708

Quick Facts

Study Start:2022-08-01
Study Completion:2026-09-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05317637

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:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Not specified
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Individuals who are able to give informed consent or have a legally authorized representative capable of giving consent on the subject's behalf
  2. * Individuals ages 18 and older of all races and sexes
  3. * Individuals who have been diagnosed with OI clinically and/or genetically
  1. * Individuals diagnosed with respiratory illness within 6 weeks of enrollment or undergoing diagnostic studies for an active illness.
  2. * Individuals with other skeletal dysplasia or genetic diagnosis
  3. * Individuals diagnosed with cardiopulmonary comorbidities that affect lung compliance

Contacts and Locations

Study Contact

Dianne Nguyen
CONTACT
713.798.6694
diannen@bcm.edu

Principal Investigator

Vernon Sutton, MD
PRINCIPAL_INVESTIGATOR
Baylor College of Medicine
Kathleen Raggio
STUDY_CHAIR
Hospital for Special Surgery, New York

Study Locations (Sites)

University of California Los Angeles
Los Angeles, California, 90095
United States
Kennedy Krieger Institute / Hugo W. Moser Research Institute
Baltimore, Maryland, 21205
United States
Hospital for Special Surgery
New York, New York, 10021
United States

Collaborators and Investigators

Sponsor: Baylor College of Medicine

  • Vernon Sutton, MD, PRINCIPAL_INVESTIGATOR, Baylor College of Medicine
  • Kathleen Raggio, STUDY_CHAIR, Hospital for Special Surgery, New York

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 Date2022-08-01
Study Completion Date2026-09-01

Study Record Updates

Study Start Date2022-08-01
Study Completion Date2026-09-01

Terms related to this study

Additional Relevant MeSH Terms

  • Osteogenesis Imperfecta