Clinical trial NCT05052606: Inspiring New Science In Guiding Healthcare in Turner Syndrome Registry
Official title: INSIGHTS Registry - Inspiring New Science In Guiding Healthcare in Turner Syndrome
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Turner Syndrome
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2021-09-22
Enrollment: 5000
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population for this registry is patients diagnosed with Turner syndrome who are seen at a participating clinic.

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.


Eligibility criteria: Inclusion Criteria:

1. 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)
2. Informed consent/assent as appropriate

Exclusion Criteria:

a. Lack of a TS diagnosis on file

Primary outcomes:
measure: Health conditions
timeFrame: From study start until condition observed, up to 15 years
Secondary outcomes:
measure: Prevalence of mental health diagnoses
timeFrame: From study start until condition observed, up to 15 years
measure: Prevalence of premature ovarian insufficiency
timeFrame: From study start until condition observed, up to 15 years
measure: Prevalence of hearing loss
timeFrame: From study start until condition observed, up to 15 years
measure: Cardiometabolic diagnoses - prevalence of obesity
timeFrame: From study start until condition observed, up to 15 years
measure: Cardiometabolic diagnoses - prevalence of dyslipidemia
timeFrame: From study start until condition observed, up to 15 years
measure: Cardiometabolic diagnoses - prevalence of fatty liver disease
timeFrame: From study start until condition observed, up to 15 years
measure: Cardiometabolic diagnoses - prevalence of hypertension
timeFrame: From study start until condition observed, up to 15 years
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
city: Washington
country: United States
facility: Children's National
state: District of Columbia
city: Glenview
country: United States
facility: Lurie Children's
state: Illinois
city: Lawrence
country: United States
facility: University of Kansas
state: Kansas
city: Chapel Hill
country: United States
facility: UNC Hospitals Children's Specialty Clinic
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Columbus
country: United States
facility: Nationwide Childern's Hospital
state: Ohio
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
city: Seattle
country: United States
facility: Seattle Children's
state: Washington
Study officials:
affiliation: Children's Hospital Colorado
name: Shanlee M Davis, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: