Turner SyndromeINSIGHTSNCT05052606
Inspiring New Science In Guiding Healthcare in Turner Syndrome Registry
An observational study of Turner Syndrome, run by University of Colorado, Denver at 10 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Turner Syndrome
- How many people
- 5,000 participants
- Where
- 10 sitesUnited States
- Study dates
- 20 May 2020to Oct 2025
- How long will I take part?
- 20 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population for this registry is patients diagnosed with Turner syndrome who are seen at a participating clinic.
Who may be able to join
- 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
Who cannot join
- Lack of a TS diagnosis on file
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites, 10 recruiting
- Recruiting
Children's Hospital Colorado
Aurora, Colorado, 80045
Shanle M Davis, MD, PhD, 720-777-6073, shanlee.davis@childrenscolorado.org
- Recruiting
UNC Hospitals Children's Specialty Clinic
Chapel Hill, North Carolina, 27514
Jennifer Law, MD, MSCR, lawj@med.unc.edu
- Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Iris Gutmark-Little, MD, iris.little@cchmc.org
- Recruiting
Nationwide Childern's Hospital
Columbus, Ohio, 43205
Jennifer Ladd, MD, MSc, 614-722-4425, jennifer.ladd@nationwidechildrens.org
Jennifer Ladd, MD, MSc
- Recruiting
Lurie Children's
Glenview, Illinois, 60026
Wendy J Brickman, MD, wbrickman@luriechildrens.org
- Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Siddharth K Prakash, MD, siddharth.k.prakash@uth.tmc.edu
- Recruiting
University of Kansas
Lawrence, Kansas, 66045
Kelsie Kelly, MD, kkelly3@kumc.edu
- Recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Vaneeta Bamba, MD, bamba@email.chop.edu
- Recruiting
Seattle Children's
Seattle, Washington, 98105
Luciana T Young, MD, luciana.young@seattlechildrens.org
- Recruiting
Children's National
Washington D.C., District of Columbia, 20010
Roopa Shankar, MD, roopakshankar@gwu.edu
About this study
Official title: INSIGHTS Registry - Inspiring New Science In Guiding Healthcare in Turner Syndrome
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.
- Conditions
- Turner Syndrome
- Being tested
- No intervention
- Medical subject headings
- Turner Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
This study is an observational study without treatment intervention.
What is being measured
The primary outcome is the main question the study is designed to answer.
Health conditions
Average number of chronic diagnoses per person
Measured: From study start until condition observed, up to 15 years
Secondary outcomes (7)
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
Measured: From study start until condition observed, up to 15 years
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.
Measured: From study start until condition observed, up to 15 years
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.
Measured: From study start until condition observed, up to 15 years
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
Measured: From study start until condition observed, up to 15 years
Cardiometabolic diagnoses - prevalence of dyslipidemia
Prevalence of metabolic syndrome is defined as the number of participants in the sample with dyslipidemia in their medical record out of the total sample. Dyslipidemia will be defined as:
- Diagnosis of dyslipidemia, hypertriglyceridemia, hypercholesterolemia in a clinical encounter, problem list, and/or past medical history
- Laboratory evidence of elevated total cholesterol, LDL, triglycerides, and/or low HDL for sex and age
Measured: From study start until condition observed, up to 15 years
Cardiometabolic diagnoses - prevalence of fatty liver disease
Prevalence of fatty liver disease is defined as the number of participants in the sample with a formal diagnosis of fatty liver disease in their medical record out of the total sample. Fatty liver disease diagnosis in the medical record in a clinical encounter, problem list, and/or past medical history may also present as:
- Non-alcoholic fatty liver disease (NAFLD)
- Hepatic steatosis
- Simple fatty liver disease
- Non-alcoholic steatohepatitis
Measured: From study start until condition observed, up to 15 years
Cardiometabolic diagnoses - prevalence of hypertension
Prevalence of hypertension is defined as the number of participants in the sample with evidence of hypertension in their medical record out of the total sample. Evidence of hypertension includes:
- Formal diagnosis of hypertension in a clinical encounter, problem list, and/or past medical history
- For children under 13 years old: a blood pressure reading at or above the 95th percentile for age, height, and sex
- For children between 13 and 17 years old: a blood pressure reading at or above 130/80 mmHg
- For adults 18 years or older: a blood pressure reading at or above 140/90 mmHg
Measured: From study start until condition observed, up to 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2021
- Study start20 May 2020
- Primary completionOct 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Turner SyndromeStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 20 Years
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shanlee M Davis, MD, PhD, Principal investigator, Children's Hospital Colorado
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05052606
- Sponsor's protocol ID
- 19-3027
- Acronym
- INSIGHTS
- Status last verified
- Sep 2024
- First submitted
- 20 Aug 2021
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INSIGHTS Registry - Inspiring New Science In Guiding Healthcare in Turner Syndrome
- ClinicalTrials.gov ID
- NCT05052606
- Acronym / sponsor ID
- INSIGHTS / 19-3027
- Conditions
- Turner Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 20 May 2020 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 22 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 20 Years
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population for this registry is patients diagnosed with Turner syndrome who are seen at a participating clinic.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Lack of a TS diagnosis on file
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionThis study is an observational study without treatment intervention. | Other | – |
Primary outcome
Health conditions
Time frame: From study start until condition observed, up to 15 years
Average number of chronic diagnoses per person
7 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shanlee M Davis, MD, PhD principal investigator
Children's Hospital Colorado
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Turner Syndrome, run by University of Colorado, Denver at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shanlee M Davis, MD, PhD (720-777-6073, shanlee.davis@childrenscolorado.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health conditions (time frame: From study start until condition observed, up to 15 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.