NCT03185702

Brief Summary

The investigators will conduct genetic comparisons between Turner Syndrome (TS) patients with and without Bicuspid Aortic Valve (BAV) to identify causative agents of BAV in people with TS. The investigators will correlate the patterns and prevalence of structural heart defects in TS women with emerging molecular data to identify patients who are at high risk for cardiovascular complications

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
103mo left

Started Aug 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress56%
Aug 2015Jan 2035

Study Start

First participant enrolled

August 28, 2015

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

June 9, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 14, 2017

Completed
12.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2030

Expected
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2035

Last Updated

November 28, 2023

Status Verified

November 1, 2023

Enrollment Period

14.4 years

First QC Date

June 9, 2017

Last Update Submit

November 27, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Bicuspid aortic valve and thoracic aortic aneurysm

    Imaging data

    10 years

Secondary Outcomes (1)

  • Health-related quality of life

    10 years

Study Arms (2)

Patients with Turner Syndrome

Chromosomal diagnosis and typical features

Genetic: Research genetic tests

Unaffected controls

Normal females and unaffected family members

Genetic: Research genetic tests

Interventions

DNA and tissue-based tests: karyotype, copy number variants, genome-wide association studies and induced pluripotent stem cells

Patients with Turner SyndromeUnaffected controls

Eligibility Criteria

Sexfemale
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study population consists of females diagnosed with Turner Syndrome. This diagnosis can be based on physical symptoms (e.g. short stature, developmental delay, pubertal delay, etc.) or karyotype (e.g. 45X/46XX mosaic, 45X, etc.).

You may qualify if:

  • Diagnosis of Turner Syndrome

You may not qualify if:

  • Diagnosis excluding Turner Syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Health Science Center Houston

Houston, Texas, 77030, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Saliva, blood, and tissue samples

MeSH Terms

Conditions

Turner Syndrome

Condition Hierarchy (Ancestors)

Gonadal DysgenesisDisorders of Sex DevelopmentUrogenital AbnormalitiesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesSex Chromosome Disorders of Sex DevelopmentMale Urogenital DiseasesHeart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSex Chromosome DisordersChromosome DisordersGenetic Diseases, InbornGonadal DisordersEndocrine System Diseases

Central Study Contacts

Siddharth Prakash, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Internal Medicine

Study Record Dates

First Submitted

June 9, 2017

First Posted

June 14, 2017

Study Start

August 28, 2015

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

January 1, 2035

Last Updated

November 28, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will share

De-identified genetic and clinical IPD data will be shared with approved researchers with local IRB approval after authorization from the UTHouston study team. Aggregate data will be made available to the general research community through NIH databases.

Locations