9101: GALAXY - Frequently Asked Questions

What is the GALAXY Registry?

GALAXY is a Multicenter clinical data registry and biorepository for individuals with X&Y variations to:

Quantify baseline clinical outcomes
Determine best clinical practices
Support future research and quality improvement to ultimately improve outcomes for individuals with X and Y variations.

Why is GALAXY important?

We need to catch X and Y variations up! X and Y variations are under-recognized, under-diagnosed, and under-studied. We need to change this!

The demographic landscape is changing with more early diagnoses.
Individually, still “rare disease”, and there is power in numbers.
Organized data collection and repository has potential to answer so many questions
“Clinical trial readiness” – to successfully do intervention studies

Why is it important or worth it for me to sign up?

Each person with an X and Y variation is unique! It is important that the Registry represent everyone’s story. X and Y variations are rare. The more participants we have, the more confident we can be that what we find is true.

How do I know my data are private or secure?

We follow all federal, state and University rules, laws, and regulations to protect your privacy.
GALAXY is overseen by a regulatory board called the Colorado Multiple Institutional Review Board that makes sure we are following all the rules and regulations.
All data are stored in Research Electronic Data Capture, or REDCap. This is a HIPAA-compliant, password protected, online database designed to store secure research information.
We use a study ID system where each participant is assigned a number. Most people will just see that number, and not your name.
Only individuals approved by the PI with required training have access to REDCap.
When we present or publish information from the registry, we group data together to give summary information.
Sponsors (including AXYS, XXYY Project, NIH, and any others) do not have access to identifiable data.

What is the minimum amount I have to do?

Sign the consent form online or at a participating clinic. If you’re signing online, either upload your genetic test or tell us where it was done at and give us permission to get it for you.

Why do you need my genetic test results?

We need to make sure you have a genetically confirmed X and Y variation. We also need to know the exact karyotype, for example if you have XXY or XXYY or if you have multiple cell lines. The genetic test also contains other useful information, such as the date of the test and what symptoms, if any, led to genetic testing.

What if I don’t have my genetic test results?

You can sign a Release of Records. This allows the study team to reach out to the clinic where you had the test done at and we can get a copy that way instead.

Chromosome analysis (karyotype) from CVS, amnio or postnatal (any tissue)
FISH from any tissue
Microarray
Specific panel identifying X&Y aneuploidy
Whole exome or genome sequencing

If you do not have a copy of your genetic test results, consider talking to your doctor about ordering as this is important for your records, too.

What else is involved? What are the options?

Give permission to access medical records. The basis of GALAXY is longitudinal clinical data (clinic visits, labs, medications, etc.). If you have received care at any place other than a GALAXY clinic, we need your permission to request these records.
Join the future studies list. We can contact you with studies that you may be interested in. This is usually only a few emails per year. You can then learn more about the study and decide if you want to participate.
Complete surveys. Medical records only tell part of the story. Some information is better coming directly from you!
Biobank. Blood sample at a GALAXY clinic location.

How do I sign up?

Sign up online: redcap.link/GALAXY-consent
Sign up online by scanning the QR code
Or talk to your doctor at a participating GALAXY clinic to sign up in-person.