Recruiting

Observational Study

Sponsor:

University of Colorado, Denver

Code:

NCT05052606

Conditions

Turner Syndrome

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

Interventions

No intervention

Study Details

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.

Conditions

Turner Syndrome

Study ID

NCT05052606

Start date

May 20, 2020

Status verified date

Sep, 2024

Completion date

Oct, 2025

Anticipated

Primary completion date

Oct, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

5000 participants

Anticipated

Interventions and Outcome Measures

Interventions

No intervention

This study is an observational study without treatment intervention.

Primary outcome measure

  • Health conditions [ Time Frame: From study start until condition observed, up to 15 years ]

Central Contacts and Locations

Central contacts

Shanlee M Davis, MD, PhD

720-777-6073shanlee.davis@childrenscolorado.org

Locations

Children's Hospital Colorado

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Shanle M Davis, MD, PhD

720-777-6073shanlee.davis@childrenscolorado.org

Children's National

Recruiting

Washington, District of Columbia, United States, 20010

Contacts

Roopa Shankar, MD

roopakshankar@gwu.edu

Lurie Children's

Recruiting

Glenview, Illinois, United States, 60026

Contacts

Wendy J Brickman, MD

wbrickman@luriechildrens.org

University of Kansas

Recruiting

Lawrence, Kansas, United States, 66045

Contacts

Kelsie Kelly, MD

kkelly3@kumc.edu

UNC Hospitals Children's Specialty Clinic

Recruiting

Chapel Hill, North Carolina, United States, 27514

Contacts

Jennifer Law, MD, MSCR

lawj@med.unc.edu

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Iris Gutmark-Little, MD

iris.little@cchmc.org

Nationwide Childern's Hospital

Recruiting

Columbus, Ohio, United States, 43205

Contacts

Jennifer Ladd, MD, MSc

614-722-4425jennifer.ladd@nationwidechildrens.org

Principal Investigator:

Jennifer Ladd, MD, MSc

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Vaneeta Bamba, MD

bamba@email.chop.edu

The University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Siddharth K Prakash, MD

siddharth.k.prakash@uth.tmc.edu

Seattle Children's

Recruiting

Seattle, Washington, United States, 98105

Contacts

Luciana T Young, MD

luciana.young@seattlechildrens.org

More Information

Sponsor

University of Colorado, Denver

Last update posted

Oct 1, 2024

Last verified

Sep, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2024-10-01.