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RecruitingOBSERVATIONAL

OverTTuRe: Characteristics, Treatment Patterns and Outcomes of Patients With ATTR Amyloidosis

This study, called OverTTuRe, is observing people with a condition called ATTR amyloidosis. It's not a trial where new treatments are tested; instead, researchers are gathering information from existing medical records. The aim is to understand how ATTR amyloidosis affects people from before diagnosis, through their treatment journey, and over time. This includes looking at symptoms, how people's daily lives are impacted, and the types of healthcare they receive. By collecting this 'real-world' data, scientists hope to gain a clearer picture of the condition and how it affects patients in the UK and other countries. The study will help improve understanding of ATTR amyloidosis and could inform future care.

At a glance

Status
Recruiting
Sponsor
AstraZeneca
Enrolment target
52,121
Start
21 Aug 2023
Estimated completion
30 Sep 2026

What is this study about?

This study, named OverTTuRe, is designed to help us better understand a condition called ATTR amyloidosis. It's an 'observational' study, which means researchers will look at information that has already been collected from existing medical records, rather than asking patients to try new treatments or have extra tests. Think of it like putting together a detailed jigsaw puzzle from pieces that are already available.

The main goal is to build a clearer picture of what it's like to live with ATTR amyloidosis. This includes understanding the typical journey people go through, from when they first show symptoms, to getting a diagnosis, and how the condition progresses over time. Researchers will also look at the different types of treatments people receive, how the condition affects their quality of life, and what kind of support and healthcare services they use.

By gathering this real-world information, scientists hope to learn more about how ATTR amyloidosis presents itself, how it's managed, and the challenges people face. This improved understanding can then help medical professionals make better decisions about care in the future and could even guide the development of new treatments and support for patients.

Key takeaways

  • This study looks at real-world information from people with ATTR amyloidosis.
  • It helps researchers understand how the condition progresses and is treated.
  • No new treatments or tests are involved for patients.
  • Patient identities are protected; only anonymised data is used.
  • The findings could lead to better care for ATTR amyloidosis in the future.

Who may be eligible?

To be included in this study, you generally need to be over 18 years old. The important part is that your medical records must show a diagnosis of ATTR amyloidosis, or that you've received a specific treatment for it, or that a biopsy (a small tissue sample) confirmed you have ATTR amyloidosis.

This study focuses specifically on ATTR amyloidosis. Therefore, if your medical records show you have other types of amyloidosis, such as AL amyloidosis (primary) or AA amyloidosis (secondary), you wouldn't be included. This is because these types of amyloidosis are different and are often treated differently.

Also, if your records indicate you've had a stem cell transplant or certain types of chemotherapy for conditions that are typically treatments for AL or AA amyloidosis, you would not be included in this particular study, as it aims to focus purely on ATTR amyloidosis.

Quick self-check
  • Are you aged 18 or over?
  • Do your medical records show a formal diagnosis of ATTR amyloidosis?
  • Have you received a specific treatment for ATTR amyloidosis?
  • Have you had a biopsy that confirmed ATTR amyloidosis?
  • Do you NOT have AL (primary) or AA (secondary) amyloidosis?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

Since this is an observational study that uses existing medical records, patients don't actively 'participate' in the traditional sense. You wouldn't need to attend any extra appointments, take any study medication, or have additional tests. Your daily routine and medical care would remain exactly the same. Researchers are simply looking back at information already collected by your doctors. Therefore, there's no specific duration of participation for you, as they are reviewing records of your journey over time. Your participation would be passive, meaning your de-identified data (information that doesn't identify you personally) might be included if it fits the study criteria.

Potential risks and benefits

Because this study is observational and uses existing, anonymised medical records, there are essentially no direct risks or benefits to individual patients. You won't undergo any procedures, take new medicines, or do anything differently. Your identity will be protected, and the information used will not be linked back to you personally. The main benefit is to the wider patient community, as the findings could improve our understanding of ATTR amyloidosis, potentially leading to better care and treatments in the future. You always have the right to ask your healthcare provider if your anonymised data is being used for research and to understand the processes for protecting your privacy.

Locations (26)

  • Research Site
    Eden Prairie, United States· Completed
  • Research Site
    Calgary, Canada· Recruiting
  • Research Site
    Beijing, China· Completed
  • Research Site
    Changsha, China· Completed
  • Research Site
    Chengdu, China· Completed
  • Research Site
    Guangzhou, China· Completed
  • Research Site
    Wuhan, China· Completed
  • Research Site
    Horsens, Denmark· Completed
  • Research Site
    Berlin, Germany· Completed
  • Research Site
    Tokyo, Japan· Completed
  • Research Site
    Lisbon, Portugal· Recruiting
  • Research Site
    Porto, Portugal· Not yet recruiting

+14 more sites — see the official record for the full list.

Common questions

What is ATTR amyloidosis?

ATTR amyloidosis is a condition where abnormal protein (amyloid) builds up in organs and tissues, affecting their normal function.

Will I have to do anything differently if my records are used?

No, you won't need to do anything differently. This study uses existing medical records, so your treatment and care will continue as normal.

Will my personal information be shared?

No, your personal information will be kept confidential. Researchers will only use anonymised data, meaning it can't be traced back to you.

How will this study help people with ATTR amyloidosis?

By understanding the condition better through real-world patient experiences, the study hopes to improve future diagnosis, treatment, and care.

What does 'observational' mean in a study?

An observational study means researchers watch and collect information from existing sources without directly influencing patient care or giving new treatments.

How to find out more

AstraZeneca Clinical Study Information Center

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 "OverTTuRe: Characteristics, Treatment Patterns and Outcomes …" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

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