[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06373861":3,"trial-entities:NCT06373861":98,"trial-summary:NCT06373861":106},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":30,"primary_purpose":17,"phases":31,"enrollment_info":32,"interventions":35,"primary_outcomes":39,"secondary_outcomes":44,"sex":63,"minimum_age":64,"maximum_age":65,"healthy_volunteers":66,"eligibility_criteria":67,"std_ages":71,"locations":75,"central_contacts":91,"overall_officials":93,"references":96,"see_also_links":97},"NCT06373861","20-0482","Generating Advancements Through Longitudinal Analysis in X and Y Variations (GALAXY)","Generating Advancements Through Longitudinal Analysis in X and Y Variations","RECRUITING","2037-04","2024-04","2024-04-18","2022-04-28","University of Colorado, Denver","OTHER",false,"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.",null,[19],"Sex Chromosome Aneuploidy",[21,22,23,24,25,26,27,28,29],"X&Y variations","chromosome variations","Klinefelter","XXY","XXX","XYY","tetrasomy","pentasomy","trisomy","OBSERVATIONAL",[],{"count":33,"type":34},5000,"ESTIMATED",[36],{"type":14,"name":37,"description":38},"no intervention","This study is an observational study without treatment intervention.",[40],{"measure":41,"description":42,"timeFrame":43},"Health Conditions","Average number of chronic diagnoses per person","From study start until condition observed, up to 15 years",[45,48,51,54,57,60],{"measure":46,"description":47,"timeFrame":43},"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\u002For past medical history:\n\n* Depression\n* Anxiety\n* Mood disorder NOS\n* Psychotic disorder\n* Attention-deficit\u002Fhyperactivity disorder (ADHD)\n* Autistic disorder",{"measure":49,"description":50,"timeFrame":43},"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.\n\nParticipants will be considered to have obesity if:\n\n* There is a diagnosis of obesity in the medical record in a clinical encounter, problem list, and\u002For past medical history\n* For children 17 years and younger: there is an available growth chart\u002Fheight\u002Fweight\u002Fother data necessary to calculate the BMI-for-age and the BMI-for-age is at or above the 95th percentile\n* For adults 18 years and older: there is a BMI at or above 30 kg\u002Fm2 or the data necessary to calculate BMI and it is at or above 30 kg\u002Fm2",{"measure":52,"description":53,"timeFrame":43},"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:\n\n* Diagnosis of dyslipidemia, hypertriglyceridemia, hypercholesterolemia in a clinical encounter, problem list, and\u002For past medical history\n* Laboratory evidence of elevated total cholesterol, LDL, triglycerides, and\u002For low HDL for sex and age",{"measure":55,"description":56,"timeFrame":43},"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:\n\n* Formal diagnosis of hypertension in a clinical encounter, problem list, and\u002For past medical history\n* For children under 13 years old: a blood pressure reading at or above the 95th percentile for age, height, and sex\n* For children between 13 and 17 years old: a blood pressure reading at or above 130\u002F80 mmHg\n* For adults 18 years or older: a blood pressure reading at or above 140\u002F90 mmHg",{"measure":58,"description":59,"timeFrame":43},"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.",{"measure":61,"description":62,"timeFrame":43},"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.","ALL","0 Days","100 Years",true,{"inclusion":68,"exclusion":69,"raw_text":70},[],[],"Inclusion Criteria:\n\n1. Genetically-confirmed diagnosis of a sex chromosome aneuploidy condition\n2. Any age\n3. Any gender\n4. Informed consent for individuals \\>18 years of age, parent\u002Fguardian permission for individuals \\\u003C18 or proxy-consent from legally authorized representative if impaired decision making\n\nExclusion Criteria:\n\na. Lack of documentation of genetic testing confirming SCA diagnosis",[72,73,74],"CHILD","ADULT","OLDER_ADULT",[76],{"facility":77,"status":8,"city":78,"state":79,"zip":80,"country":81,"contacts":82,"geoPoint":88},"Children's Hospital Colorado","Aurora","Colorado","80045","United States",[83],{"name":84,"role":85,"phone":86,"email":87},"Shanlee M Davis, MD, PhD","CONTACT","720-777-6073","shanlee.davis@childrenscolorado.org",{"lat":89,"lon":90},39.72943,-104.83192,[92],{"name":84,"role":85,"phone":86,"email":87},[94],{"name":84,"affiliation":77,"role":95},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":99,"biomarkers":105},[100,101,102,19,103,104],"47,XYY Syndrome","Klinefelter Syndrome","Pentasomy","Tetrasomy X syndrome","Trisomy X",[],{"nct_id":4,"found":66,"summary":107,"prompt_version":117},{"design":108,"status":109,"heading":110,"summary":111,"follow_up":112,"word_count":113,"commitments":114,"compensation":115,"drugs_mentioned":116},"This is an observational study that plans to include up to 5000 participants. It is a registry that collects information from medical records.","completed","GALAXY: Understanding X and Y Variations","The GALAXY study is a registry that aims to learn more about people with sex chromosome aneuploidy (X&Y variations). This study does not involve any treatment. Instead, researchers will collect information from your medical records, such as genetic tests, imaging results, and medications, from clinics across the US. The goal is to gather this information to improve health outcomes and care for individuals with X&Y variations. You can join if you have a genetically-confirmed diagnosis of a sex chromosome aneuploidy condition, are any age, and any gender. The study will look at health conditions from the start of the study for up to 15 years.","Health conditions will be observed from the study start until a condition is seen, for up to 15 years.",105,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]