Generating Advancements Through Longitudinal Analysis in X and Y Variations (GALAXY)

NCT ID: NCT06373861

Last Updated: 2024-04-18

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

2022-04-28

Study Completion Date

2037-04-30

Brief Summary

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GALAXY is a registry research study that plans to learn more about individuals with X\&Y variations (also called sex chromosome aneuploidies) through collecting information from medical records.This includes genetic tests, imaging, medications, and more for hundreds of patients seen at a number of clinics across the US. The purpose of the GALAXY Registry is to collect and store this information with the overall goal to improve health outcomes in individuals with X\&Y variations and the care they receive.

Detailed Description

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Conditions

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Sex Chromosome Aneuploidy

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. Genetically-confirmed diagnosis of a sex chromosome aneuploidy condition
2. Any age
3. Any gender
4. Informed consent for individuals \>18 years of age, parent/guardian permission for individuals \<18 or proxy-consent from legally authorized representative if impaired decision making

Exclusion Criteria

a. Lack of documentation of genetic testing confirming SCA diagnosis
Minimum Eligible Age

0 Days

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Children's Hospital Colorado

OTHER

Sponsor Role collaborator

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

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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Shanlee M Davis, MD, PhD

Role: primary

720-777-6073

Other Identifiers

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20-0482

Identifier Type: -

Identifier Source: org_study_id

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