Inspiring New Science In Guiding Healthcare in Turner Syndrome Registry
INSIGHTS
INSIGHTS Registry - Inspiring New Science In Guiding Healthcare in Turner Syndrome
1 other identifier
observational
5,000
1 country
10
Brief Summary
INSIGHTS is a registry research study that collects key information on medical history for girls and women with Turner syndrome and the clinical care they receive. This includes genetic tests, imaging, medications, and more for hundreds of patients seen at a number of clinics across the US. In addition to learning a lot about the current state of health for individuals with TS, INSIGHTS serves as an infrastructure to conduct future studies are meaningful to patients and their families.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2020
Longer than P75 for all trials
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 20, 2020
CompletedFirst Submitted
Initial submission to the registry
August 20, 2021
CompletedFirst Posted
Study publicly available on registry
September 22, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2025
CompletedOctober 1, 2024
September 1, 2024
5.4 years
August 20, 2021
September 27, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Health conditions
Average number of chronic diagnoses per person
From study start until condition observed, up to 15 years
Secondary Outcomes (7)
Prevalence of mental health diagnoses
From study start until condition observed, up to 15 years
Prevalence of premature ovarian insufficiency
From study start until condition observed, up to 15 years
Prevalence of hearing loss
From study start until condition observed, up to 15 years
Cardiometabolic diagnoses - prevalence of obesity
From study start until condition observed, up to 15 years
Cardiometabolic diagnoses - prevalence of dyslipidemia
From study start until condition observed, up to 15 years
- +2 more secondary outcomes
Interventions
This study is an observational study without treatment intervention.
Eligibility Criteria
The study population for this registry is patients diagnosed with Turner syndrome who are seen at a participating clinic.
You may qualify if:
- Individuals with TS and TS variants as defined by the TS Clinical Practice Guideline definition (karyotype consistent with TS, phenotypic female, clinical feature(s) of TS)
- Informed consent/assent as appropriate
You may not qualify if:
- a. Lack of a TS diagnosis on file
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Children's Hospital Colorado
Aurora, Colorado, 80045, United States
Children's National
Washington D.C., District of Columbia, 20010, United States
Lurie Children's
Glenview, Illinois, 60026, United States
University of Kansas
Lawrence, Kansas, 66045, United States
UNC Hospitals Children's Specialty Clinic
Chapel Hill, North Carolina, 27514, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Nationwide Childern's Hospital
Columbus, Ohio, 43205, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
The University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
Seattle Children's
Seattle, Washington, 98105, United States
Biospecimen
If resources are available and optional consent is provided, a 5-10mL blood sample will be obtained in 1 gold top and 1 purple top (EDTA) tube and processed for storage of plasma, serum, and buffy coat. These specimens will be stored in a biobank with a barcode to link the sample with the patient for future studies involving the assessment of hormones, proteins, metabolites, DNA, RNA, and other studies. Phlebotomy will be combined with clinical phlebotomy whenever possible.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shanlee M Davis, MD, PhD
Children's Hospital Colorado
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Target Duration
- 20 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 20, 2021
First Posted
September 22, 2021
Study Start
May 20, 2020
Primary Completion
October 1, 2025
Study Completion
October 1, 2025
Last Updated
October 1, 2024
Record last verified: 2024-09