Sex Chromosome AneuploidyGALAXYNCT06373861
Generating Advancements Through Longitudinal Analysis in X and Y Variations (GALAXY)
An observational study of Sex Chromosome Aneuploidy, run by University of Colorado, Denver at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 0 days to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Sex Chromosome Aneuploidy
- How many people
- 5,000 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Apr 2022to Apr 2037
- How long will I take part?
- 20 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 days to 100 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study population for this registry is patients diagnosed with sex chromosome aneuploidy (SCA) conditions throughout the lifespan.
Who may be able to join
- Genetically-confirmed diagnosis of a sex chromosome aneuploidy condition
- Any age
- Any gender
- 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
Who cannot join
- Lack of documentation of genetic testing confirming SCA diagnosis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Children's Hospital Colorado
Aurora, Colorado, 80045
Shanlee M Davis, MD, PhD, 720-777-6073, shanlee.davis@childrenscolorado.org
About this study
Official title: Generating Advancements Through Longitudinal Analysis in X and Y Variations
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.
- Conditions
- Sex Chromosome Aneuploidy
- Being tested
- no intervention
- Keywords
- X&Y variations, chromosome variations, Klinefelter, XXY, XXX, XYY, tetrasomy, pentasomy, trisomy
- Medical subject headings
- Klinefelter Syndrome, Tetrasomy, Trisomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
This study is an observational study without treatment intervention.
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Conditions
Average number of chronic diagnoses per person
Measured: From study start until condition observed, up to 15 years
Secondary outcomes (6)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: From study start until condition observed, up to 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2024
- Study start28 Apr 2022
- Primary completionApr 2037 (estimated)
- Study completionApr 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sex Chromosome AneuploidyStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 20 Years
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital Colorado
- Responsible party
- Sponsor
- Investigators
- Shanlee M Davis, MD, PhD, Principal investigator, Children's Hospital Colorado
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06373861
- Sponsor's protocol ID
- 20-0482
- Acronym
- GALAXY
- Status last verified
- Apr 2024
- First submitted
- 15 Apr 2024
- Last updated
- 18 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Generating Advancements Through Longitudinal Analysis in X and Y Variations
- ClinicalTrials.gov ID
- NCT06373861
- Acronym / sponsor ID
- GALAXY / 20-0482
- Conditions
- Sex Chromosome Aneuploidy
- Keywords
- X&Y variations, chromosome variations, Klinefelter, XXY, XXX, XYY, tetrasomy, pentasomy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Children's Hospital Colorado
- Study start
- 28 Apr 2022 (actual)
- Primary completion
- Apr 2037 (estimated)
- Study completion
- Apr 2037 (estimated)
- First posted
- 18 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 20 Years
Who may qualify
- Ages
- 0 days to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population for this registry is patients diagnosed with sex chromosome aneuploidy (SCA) conditions throughout the lifespan.
Key inclusion criteria (4 listed)
- Genetically-confirmed diagnosis of a sex chromosome aneuploidy condition
- Any age
- Any gender
- 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
Key exclusion criteria (1 listed)
- Lack of documentation of genetic testing confirming SCA diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionThis study is an observational study without treatment intervention. | Other | – |
Primary outcome
Health Conditions
Time frame: From study start until condition observed, up to 15 years
Average number of chronic diagnoses per person
6 secondary outcomes
Prevalence of mental health diagnoses
Time frame: From study start until condition observed, up to 15 years
Cardiometabolic diagnoses - prevalence of obesity
Time frame: From study start until condition observed, up to 15 years
Cardiometabolic diagnoses - prevalence of dyslipidemia
Time frame: From study start until condition observed, up to 15 years
Cardiometabolic diagnoses-prevalence of hypertension
Time frame: From study start until condition observed, up to 15 years
Autoimmune diagnoses - prevalence of hypothyroidism and of hyperthyroidism
Time frame: From study start until condition observed, up to 15 years
Autoimmune diagnoses - prevalence of diabetes
Time frame: From study start until condition observed, up to 15 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
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Pregnant Individuals, Aneuploidy
RecruitingPhase 1
A Multiple Baseline Feasibility Trial of Social Management Training for People With Sex Chromosome Aneuploidies
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shanlee M Davis, MD, PhD principal investigator
Children's Hospital Colorado
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sex Chromosome Aneuploidy, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shanlee M Davis, MD, PhD (720-777-6073, shanlee.davis@childrenscolorado.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health Conditions (time frame: From study start until condition observed, up to 15 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2024.