Inspiring New Science In Guiding Healthcare in Turner Syndrome Registry
ConditionTurner Syndrome
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
AgeNot listed
SponsorUniversity of Colorado, Denver
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial population
The study population for this registry is patients diagnosed with Turner syndrome who are seen at a participating clinic.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
No intervention
Other interventionThis study is an observational study without treatment intervention.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Health conditions
Average number of chronic diagnoses per person
Time frame
From study start until condition observed, up to 15 yearsSecondary outcomes
1
Prevalence of mental health diagnoses
Prevalence of mental health diagnoses is defined as the number of participants in the sample diagnosed with a mental health disorder by a clinician according to their medical record out of the total sample. This will be determined by a diagnosis of any of the following in a clinical encounter, problem list, and/or past medical history: * Depression * Anxiety * Mood disorder NOS * Psychotic disorder * Attention-deficit/hyperactivity disorder (ADHD) * Autistic disorder
Time frame
From study start until condition observed, up to 15 years2
Prevalence of premature ovarian insufficiency
Prevalence of premature ovarian insufficiency is defined as the number of participants in the sample with a diagnosis of premature ovarian insufficiency (or failure) in their medical record clinical encounter, problem list, and/or past medical history or laboratory results in their medical record consistent with this diagnosis (elevated FSH or undetectable AMH) out of the total sample.
Time frame
From study start until condition observed, up to 15 years3
Prevalence of hearing loss
Prevalence of hearing loss is defined as the number of participants in the sample formally diagnosed with a hearing loss in their medical record in a clinical encounter, problem list, and/or past medical history or an audiology report consistent with hearing impairment out of the total sample.
Time frame
From study start until condition observed, up to 15 years4
Cardiometabolic diagnoses - prevalence of obesity
Prevalence of obesity is defined as the number of participants in the sample with obesity in their medical record out of the total sample. Obesity in pediatric populations is determined using BMI-for-age and obesity in adult populations is determined using BMI. BMI is calculated as the weight in kilograms divided by the height in meters squared. Participants will be considered to have obesity if: * There is a diagnosis of obesity in the medical record in a clinical encounter, problem list, and/or past medical history * For children 17 years and younger: there is an available growth chart/height/weight/other data necessary to calculate the BMI-for-age and the BMI-for-age is at or above the 95th percentile * For adults 18 years and older: there is a BMI at or above 30 kg/m2 or the data necessary to calculate BMI and it is at or above 30 kg/m2
Time frame
From study start until condition observed, up to 15 yearsSponsors and contacts
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Source ClinicalTrials.gov