An observational study in Sex Chromosome Aneuploidy, sponsored by University of Colorado, Denver. Recruiting at 1 site in United States. Open to participants aged 0 Days to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-18.
Sponsored by University of Colorado, Denver · Observational
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.
47 studies on the registry are indexed under Klinefelter Syndrome; 17 are open to participants now.
This study's planned enrollment of 5,000 is above the median of 300 across 27 observational studies indexed under Klinefelter Syndrome.
Browse Klinefelter Syndrome studies →University of Colorado, Denver is the lead sponsor of 1,543 studies on the registry; 317 are open to participants now.
Of its 147 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
The study population for this registry is patients diagnosed with sex chromosome aneuploidy (SCA) conditions throughout the lifespan.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
a. Lack of documentation of genetic testing confirming SCA diagnosis
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This study is an observational study without treatment intervention.
Health Conditions
Average number of chronic diagnoses per person
Time frame: From study start until condition observed, up to 15 years
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
Time frame: From study start until condition observed, up to 15 years
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
Time frame: From study start until condition observed, up to 15 years
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
Time frame: From study start until condition observed, up to 15 years
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
Time frame: From study start until condition observed, up to 15 years
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.
Time frame: From study start until condition observed, up to 15 years
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.
Time frame: From study start until condition observed, up to 15 years
Started Apr 2022 (actual). Primary completion is estimated for Apr 2037, 180 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Colorado, Denver →