Sex Chromosome Aneuploidy Clinical Trial
— GALAXYOfficial title:
Generating Advancements Through Longitudinal Analysis in X and Y Variations
| NCT number | NCT06373861 |
| Other study ID # | 20-0482 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | April 28, 2022 |
| Est. completion date | April 2037 |
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.
| Status | Recruiting |
| Enrollment | 5000 |
| Est. completion date | April 2037 |
| Est. primary completion date | April 2037 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 0 Days to 100 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Children's Hospital Colorado | Aurora | Colorado |
| Lead Sponsor | Collaborator |
|---|---|
| University of Colorado, Denver | Children's Hospital Colorado |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Health Conditions | Average number of chronic diagnoses per person | From study start until condition observed, up to 15 years | |
| Secondary | 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 |
From study start until condition observed, up to 15 years | |
| Secondary | 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 |
From study start until condition observed, up to 15 years | |
| Secondary | 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 |
From study start until condition observed, up to 15 years | |
| Secondary | 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 |
From study start until condition observed, up to 15 years | |
| Secondary | Autoimmune diagnoses - prevalence of hypothyroidism and of hyperthyroidism | Prevalence of hypothyroidism is defined as the number of participants in the sample with evidence of hypertension in their medical record out of the total sample. | From study start until condition observed, up to 15 years | |
| Secondary | Autoimmune diagnoses - prevalence of diabetes | Prevalence of diabetes is defined as the number of participants in the sample with evidence of hypertension in their medical record out of the total sample. Both type 1 and type 2 are included. | From study start until condition observed, up to 15 years |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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