Inspiring New Science In Guiding Healthcare in Turner Syndrome Registry

NCT ID: NCT05052606

Last Updated: 2024-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

5000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-20

Study Completion Date

2025-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Turner Syndrome

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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No intervention

This study is an observational study without treatment intervention.

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shanlee M Davis, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Colorado

Locations

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Children's Hospital Colorado

Aurora, Colorado, United States

Site Status RECRUITING

Children's National

Washington D.C., District of Columbia, United States

Site Status RECRUITING

Lurie Children's

Glenview, Illinois, United States

Site Status RECRUITING

University of Kansas

Lawrence, Kansas, United States

Site Status RECRUITING

UNC Hospitals Children's Specialty Clinic

Chapel Hill, North Carolina, United States

Site Status RECRUITING

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Site Status RECRUITING

Nationwide Childern's Hospital

Columbus, Ohio, United States

Site Status RECRUITING

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status RECRUITING

Seattle Children's

Seattle, Washington, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Shanlee M Davis, MD, PhD

Role: CONTACT

720-777-6073

Facility Contacts

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Shanle M Davis, MD, PhD

Role: primary

720-777-6073

Roopa Shankar, MD

Role: primary

Wendy J Brickman, MD

Role: primary

Kelsie Kelly, MD

Role: primary

Jennifer Law, MD, MSCR

Role: primary

Iris Gutmark-Little, MD

Role: primary

Jennifer Ladd, MD, MSc

Role: primary

614-722-4425

Vaneeta Bamba, MD

Role: primary

Siddharth K Prakash, MD

Role: primary

Luciana T Young, MD

Role: primary

Other Identifiers

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19-3027

Identifier Type: -

Identifier Source: org_study_id

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