CompletedNot Applicable

Role of Myeloid-derived Suppressor Cells In Primary Myelofibrosis

Italy70 participantsStarted 2023-11-14

Plain-language summary

The goals of this observational study are to investigate the role of myeloid-derived suppressor cells (MDSCs) in fueling chronic inflammation that is a relevant pathogenetic mechanism in patients with primary myelofibrosis (PMF), to study modifications in MDSC phenotype and function after treatment with JAK-inhibitors (JAK-i) and to test their participation in the neoangiogenic process. The main questions it aims to answer are: * Do the frequency and function of MDSCs contribute to induce or sustain the inflammatory status that characterizes PMF? * Does the number of circulating MDSCs in PMF patients correlate with clinical/biological parameters? * Are MDSCs involved in the neoangiogenic processes that characterizes PMF?

Who can participate

Age range

18 Years – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * age \>18 years; * diagnosis of primary myelofibrosis according to 2016 WHO criteria; * willing to participate and understanding and signing the I.C. Exclusion Criteria: * concurrent or recent diagnosis of an inflammatory disease and/or neoplasia; * any other condition that can confounds the ability to interpret data from the study; * concurrent pregnancy. No vulnerable participants will be enrolled in the study.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage of circulating MDSCs

Timeframe: From the first enrollment through study completion, an average of 1 year

Correlations between MDSC and clinical/genetic parameters

Timeframe: From the first enrollment through study completion, an average of 1 year

Trial details

NCT IDNCT07319026

SponsorFondazione IRCCS Policlinico San Matteo di Pavia

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-03-31

View on ClinicalTrials.gov More Primary Myelofibrosis (PMF) trials