RecruitingOBSERVATIONAL

Clinical Epidemiology in Contemporary Patients With Myelofibrosis.

This Europe-wide study is collecting important information about myelofibrosis, a rare condition that affects the bone marrow. Researchers are enrolling adult patients who have been diagnosed with myelofibrosis since January 2018. They will follow these patients over several years, collecting details about their health, symptoms, and treatments. This helps doctors learn more about how myelofibrosis progresses and how different treatments work in everyday life. By understanding these patterns, the study aims to improve care and support for people living with myelofibrosis in the future.

At a glance

Status

Recruiting

Sponsor

FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS

Enrolment target

617

Start

14 Oct 2024

Estimated completion

31 Dec 2028

Myelofibrosis

What is this study about?

Myelofibrosis is a condition where the bone marrow, which usually makes blood cells, becomes scarred. This scarring means the bone marrow can't make enough healthy blood cells, leading to problems like tiredness (anaemia) and a larger-than-normal spleen. People with myelofibrosis can also experience symptoms such as fever, night sweats, bone pain, and weight loss, which can affect their daily lives. It's a rare condition, and understanding how it affects people over time and how different treatments work is really important.

This study is a continuation of previous research where doctors have been collecting information from many patients with myelofibrosis across Europe. The medical understanding of myelofibrosis, including how it's diagnosed and treated, has been changing quite a bit over the last decade. There are new ways to diagnose it and new medicines available.

Because of these new developments, researchers want to keep tracking patients' journeys to see how these changes are affecting real-world care. By observing a large group of patients, this study helps doctors see what's happening outside of strict clinical trials, offering a clearer picture of how myelofibrosis impacts people and how treatments are used in everyday medical practice. This knowledge is crucial for developing better treatment plans and improving the quality of life for people with myelofibrosis.

Key takeaways

It's an observational study, meaning it watches existing care, not new treatments.
It collects data on myelofibrosis patients across Europe.
Aims to understand how myelofibrosis progresses and how treatments are used in real life.
Will follow patients yearly until 2028.
Helps improve future diagnosis and treatment for myelofibrosis patients.

Who may be eligible?

To be part of this study, you need to be at least 18 years old. You must have been diagnosed with myelofibrosis from January 2018 onwards. This includes both primary myelofibrosis and myelofibrosis that has developed from other blood conditions like essential thrombocythemia or polycythemia vera.

You won't be able to join if your diagnosis is for an early or 'prefibrotic' stage of myelofibrosis. Also, if you're already taking part in another clinical trial that is testing a new treatment for myelofibrosis, you won't be eligible for this study.

Quick self-check

Are you 18 years old or older?
Were you diagnosed with myelofibrosis (primary or secondary) since January 2018?
Are you not currently in another clinical trial for myelofibrosis treatments?
Have you been diagnosed with full myelofibrosis, not just an early or pre-myelofibrosis stage?

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

What does participation involve?

If you decide to take part in this study, the doctors and nurses will collect information about your myelofibrosis at your regular check-ups. This includes details about your diagnosis, symptoms, and any treatments you are receiving. They will also update this information once a year. You won't be given any new medicines or treatments as part of this study; it's purely about observing your usual care. The study aims to follow patients for several years, up until the end of 2028, or until their last available hospital visit, whichever comes first. You'll simply continue with your routine medical care for myelofibrosis, and your doctors will share your health information so researchers can learn from it.

Potential risks and benefits

The main benefit of taking part in this study is contributing to a better understanding of myelofibrosis, which can help improve diagnosis and treatment for future patients. There are very few direct risks to you because you'll continue with your standard medical care, and no new treatments are being tested. Your personal information will be handled carefully to protect your privacy. Remember, you can decide to stop being part of the study at any time, without it affecting your medical care.

Locations (36)

Hematology Center after Prof.R.H. Yeolyan
Yerevan, Armenia· Recruiting
University of Copenhagen's Roskilde Hospital
Copenhagen, Denmark· Not yet recruiting
Clinical Investigation Center of the Saint Louis Hospital
Paris, France· Not yet recruiting
Internal Medicine C, Hematology, Oncology, Stem Cell Transplantation and Palliative Care, University Medicine Greifswald
Greifswald, Germany· Not yet recruiting
University Hospital Halle Department of Hematology/Oncology
Halle, Germany· Not yet recruiting
University Clinic for Hematology, Oncology, Hemostaseology and Palliative Care Johannes Wesling Medical Center Minden UKRUB, University of Bochum
Minden, Germany· Not yet recruiting
Division of Haematology, Sasson University Hospital Assuta Ashdod, Ashdod, Ben-Gurion University of Negev
Ashdod, Israel· Not yet recruiting
A.S.O. SS. Antonio e Biagio e C.Arrigo, SC Ematologia
Alessandria, Italy· Recruiting
ASST Papa Giovanni XXIII, SC Ematologia
Bergamo, Italy· Recruiting
Policlinico S. Orsola - Malpighi, Unità di Ematologia
Bologna, Italy· Recruiting
Azienda Ospedaliero - Universitaria "Policlinico Vittorio Emanuele" - PO Gaspare Rodolico, Dipartimento di ematologia con Trapianto di midollo Osseo
Catania, Italy· Not yet recruiting
AOU Careggi di Firenze, Divisione di Ematologia
Florence, Italy· Recruiting

+24 more sites — see the official record for the full list.

Common questions

What is myelofibrosis?

Myelofibrosis is a rare condition where the bone marrow, which makes blood cells, becomes scarred and can't produce healthy red blood cells properly.

Will I receive new treatment in this study?

No, this study is about observing your current and usual medical care. You won't be given any new or experimental treatments.

How long will I be involved in the study?

Information will be collected about your health once a year, and the study aims to follow patients until the end of 2028 or your last hospital visit, whichever is sooner.

Is my personal information protected?

Yes, all your personal and health information will be handled according to strict data protection rules (like GDPR) to ensure your privacy.

Can I stop participating in the study?

Absolutely. You are free to withdraw from the study at any time without any impact on your medical care or treatment.

How to find out more

TIZIANO BARBUI, MD

tbarbui@fondazionefrom.it 0352675134 Official trial record

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