RECRUITING

VIrtual STudy in Achondroplasia for the US (VISTA)

Conditions

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

This is an observational study of individuals with achondroplasia in the United States. The primary study population consists of pediatric individuals treated and untreated with VOXZOGO™. Study enrollment started in February 2023. The projected total duration of the study is approximately 5 years at minimum from start of study recruitment in February 2023, with the duration of individual prospective follow-up differing depending on the time of enrollment. The study duration may be extended based on decisions by the study sponsor. Data will be collected in two formats for the primary pediatric study population: 1. Participant-mediated access to electronic health records(including medical imaging, when available) which will enable retrospective and prospective collection of secondary data reflecting real-life treatment use and clinical care. . 2. Primary data collection of Clinical Outcome Assessments (COAs) and questionnaire data. Data will be collected in the following format for the adult cohort: \- Participant-mediated access to electronic health records (including medical imaging, when available) which will enable retrospective and prospective collection of secondary data reflecting real-life treatment use and clinical care. The primary study population will include approximately 150 pediatric individuals with achondroplasia regardless of their treatment status with VOXZOGO™. Individuals may change status from untreated to treated during the prospective period of the study (or vice versa) however they will only be counted once, based on their treated status at the point of enrollment. The secondary study population will include 20 adolescent and adult participants.

Official Title

VIrtual STudy in Achondroplasia for the US (VISTA)

Quick Facts

Study Start:2023-02-21
Study Completion:2028-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06168201

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:0 Months to 18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Physician diagnosis of achondroplasia
  2. * Age at time of enrollment:
  3. * Receiving medical care in the United States
  4. * Complete PicnicHealth's onboarding process, including signing informed consent and authorization for medical record retrieval
  1. * Lack of any medical records

Contacts and Locations

Study Contact

Trial Specialist
CONTACT
1-800-938-4587
medinfo@bmrn.com

Principal Investigator

Medical Director, MD
STUDY_DIRECTOR
BioMarin Pharmaceutical

Study Locations (Sites)

UCSF
Oakland, California, 94609
United States
PicnicHealth
San Francisco, California, 94107
United States
Piedmont Health
Statesville, North Carolina, 28625
United States
University of Cincinnati
Cincinnati, Ohio, 45229
United States
Sanford Health
Sioux Falls, South Dakota, 57105
United States
Baylor College of Medicine
Houston, Texas, 77030-2316
United States
University of Wisconsin
Madison, Wisconsin, 53726
United States

Collaborators and Investigators

Sponsor: BioMarin Pharmaceutical

  • Medical Director, MD, STUDY_DIRECTOR, BioMarin Pharmaceutical

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 Date2023-02-21
Study Completion Date2028-02

Study Record Updates

Study Start Date2023-02-21
Study Completion Date2028-02

Terms related to this study

Additional Relevant MeSH Terms

  • Achondroplasia