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Recruiting NCT05052606

Inspiring New Science In Guiding Healthcare in Turner Syndrome Registry

— Observational Turner Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: No intervention.
Who it may be relevant to
Registry conditions: Turner Syndrome. Basic parameters: No limits · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

INSIGHTS Registry - Inspiring New Science In Guiding Healthcare in Turner Syndrome

Overview

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.

Interventions

  • Other No intervention
    This study is an observational study without treatment intervention.

Primary outcome measures

  • Health conditions [Time frame: From study start until condition observed, up to 15 years]
Secondary outcome measures (7)
  • Prevalence of mental health diagnoses [Time frame: From study start until condition observed, up to 15 years]
  • Prevalence of premature ovarian insufficiency [Time frame: From study start until condition observed, up to 15 years]
  • Prevalence of hearing loss [Time frame: From study start until condition observed, up to 15 years]
  • Cardiometabolic diagnoses - prevalence of obesity [Time frame: From study start until condition observed, up to 15 years]
  • Cardiometabolic diagnoses - prevalence of dyslipidemia [Time frame: From study start until condition observed, up to 15 years]
  • Cardiometabolic diagnoses - prevalence of fatty liver disease [Time frame: From study start until condition observed, up to 15 years]
  • Cardiometabolic diagnoses - prevalence of hypertension [Time frame: From study start until condition observed, up to 15 years]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

a. Lack of a TS diagnosis on file

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

United States · 10 centers
  • Children's Hospital Colorado — Aurora
  • Children's National — Washington D.C.
  • Lurie Children's — Glenview
  • University of Kansas — Lawrence
  • UNC Hospitals Children's Specialty Clinic — Chapel Hill
  • Cincinnati Children's Hospital Medical Center — Cincinnati
  • Nationwide Childern's Hospital — Columbus
  • Children's Hospital of Philadelphia — Philadelphia
  • … and 2 more centers

Identifiers

NCT: NCT05052606 · 19-3027

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗