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A Retrospective Study to Characterize Participants With Propionic Acidemia

This study is looking back at existing medical records of people who have a rare genetic condition called propionic acidemia (PA). It's an observational study, meaning researchers aren't giving new treatments or asking people to change anything they usually do. Instead, they are carefully reviewing old patient notes, hospital visits, and test results from various clinics and hospitals around the world. The main goal is to understand more about PA: how it affects people over time, what symptoms they experience, and how often certain health events happen. By collecting this information, researchers hope to get a clearer picture of PA, which could help in developing better ways to manage or treat the condition in the future.

At a glance

Status
Recruiting
Sponsor
ModernaTX, Inc.
Enrolment target
60
Start
16 Jun 2023
Estimated completion
30 Sep 2026

What is this study about?

This study is gathering information about a rare genetic condition called propionic acidemia (PA). In PA, the body has trouble breaking down certain proteins and fats, which can lead to a build-up of harmful substances. This study is not testing a new medicine or treatment. Instead, it's a 'retrospective' study, which means researchers are looking back at existing medical records and health information that have already been collected over time.

The main purpose of this study is to understand more about how propionic acidemia affects people. They'll be looking at things like what symptoms people experience, how often they need hospital care, and generally how the condition progresses. Gathering this detailed information from many different patients helps build a bigger picture of the condition than any single doctor might see.

By carefully reviewing these records, the researchers hope to learn more about the common patterns and challenges faced by people with PA. This knowledge is really important because it can help doctors and scientists understand the disease better, which could eventually lead to new or improved ways of caring for and treating people with propionic acidemia.

Key takeaways

  • This study helps doctors learn more about propionic acidemia.
  • It only uses existing medical records; no new treatments involved.
  • Your privacy is protected when your records are reviewed.
  • It's about understanding the disease, not testing new drugs.
  • This research aims to improve future care for PA patients.

Who may be eligible?

To be included in this study, you must have a confirmed diagnosis of propionic acidemia (PA) that was identified through a genetic test. We'll need access to your medical records from when you were born, or at least from January 1, 2015, whichever is more recent. It's also important that your records show you've had certain health events related to PA within specific timeframes.

There are some reasons why your records might not be included. For instance, if you've been part of other specific clinical studies for PA, or if you've received gene therapy or an organ transplant, your records wouldn't be suitable for this particular study. We also wouldn't be able to include records if we can no longer get important health information about you.

Patients aged 2 years and older, regardless of gender, may be considered if their medical history meets all the necessary criteria. The researchers are looking for complete records to ensure they get the best information possible about propionic acidemia.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Do I have a confirmed genetic diagnosis of propionic acidemia?
  2. Do I have medical records available from at least January 1, 2015, or since birth?
  3. Have I had certain health issues related to propionic acidemia (called MDEs) in the past?
  4. Have I avoiding participating in specific recent PA clinical trials, gene therapy, or organ transplants?
Answer every question to see your result.

What does participation involve?

Taking part in this study simply means allowing researchers to look at your existing medical history. There are no clinic visits, no new tests, and no changes to your current medications or care. You won't be asked to do anything differently than what you normally do. Your doctor and other healthcare providers will continue to look after your health as usual. The researchers will just be reviewing information already stored in your medical records, going back as far as possible, or to January 1, 2015. There is no set duration for your 'participation' as it's just about reviewing past data.

Potential risks and benefits

There are no direct medical risks to you for participating in this study, as it only involves reviewing your existing medical records; you won't undergo any procedures or take any new medications. The main potential benefit is that the information gathered from your records, combined with others, could help scientists and doctors learn more about propionic acidemia. This could ultimately lead to a better understanding of the condition and improved care or treatments for patients in the future. You always have the right to withdraw your permission for your medical records to be included at any time without affecting your medical care.

Locations (29)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • University of Stanford Medical Center
    Verified postcode
    Stanford, United States· Not yet recruiting
  • Johns Hopkins University
    Verified postcode
    Baltimore, United States· Recruiting
  • University of Michigan Hospital
    Verified postcode
    Ann Arbor, United States· Active not recruiting
  • Children's Hospital of Philadelphia
    Verified postcode
    Philadelphia, United States· Recruiting
  • Texas Children's Hospital
    Verified postcode
    Houston, United States· Terminated
  • Seattle Children's Hospital
    Verified postcode
    Seattle, United States· Recruiting
  • Royal Children's Hospital Melbourne
    Verified postcode
    Parkville, Australia· Withdrawn
  • Stollery Children's Hospital University of Alberta
    Verified postcode
    Edmonton, Canada· Withdrawn
  • CHU Toulouse
    Verified postcode
    Toulouse, France· Recruiting
  • CHRU Nancy Hôpital des Enfants
    Verified postcode
    Vandœuvre-lès-Nancy, France· Withdrawn
  • Hôpital Necker - Enfants Malades
    Verified postcode
    Paris, France· Recruiting
  • CHU de Marseille - Hôpital de la Timone
    Verified postcode
    Marseille, France· Recruiting

Common questions

What is propionic acidemia?

It's a rare genetic condition where the body has trouble breaking down certain proteins and fats, leading to a build-up of harmful substances.

Will I have to take any new medicines or have extra tests?

No, this study only looks at your existing medical records. You won't be asked to change anything about your current care.

Who is running this study?

This is a global study involving various hospitals and clinics, meaning researchers from different places are working together.

How will my personal information be kept private?

Researchers will take steps to protect your privacy when reviewing your medical records, usually by removing identifying details.

Can I decide not to be in the study if I change my mind?

Yes, you can withdraw your permission for your medical records to be used at any time, and it won't affect your medical care.

How to find out more

Moderna WeCare Team

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "A Retrospective Study to Characterize Participants With Prop…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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