NCT05440838 Identification of Factors Associated With Treatment Response in Patients With Polycythemia Vera, Essential Thrombocythemia, and Pre-myelofibrosis.
| NCT ID | NCT05440838 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Angers |
| Condition | Myeloproliferative Neoplasm |
| Study Type | OBSERVATIONAL |
| Enrollment | 120 participants |
| Start Date | 2023-05-17 |
| Primary Completion | 2027-02-17 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 120 participants in total. It began in 2023-05-17 with a primary completion date of 2027-02-17.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
First-line treatment for patients with polycythemia vera, essential thrombocythemia, and pre-myelofibrosis is based on hydroxyurea or pegylated interferon. The objective of treatment is to prevent thrombotic complications and leukemic transformation. Despite overall good response rates, some patients do not respond to treatment and others lose their response over time. Both situations are associated with worse survival and there are to date no clear predictive factors for response although the existence of additional mutations seems unfavorable. In this exploratory study, we hypothesize that biological factors at diagnosis are associated with hematological response at 12 months. We will more specifically study the association between mutational profile, assessed by next-generation sequencing, and cytokine profile with hematological response. This study will help in identifying patients who will not respond to hydroxyurea or pegylated interferon and give the opportunity to try other treatments upfront, in the perspective of precision medicine. On the basic science side, this study will help in understanding the molecular and immunological factors involved in resistance to treatment.
Eligibility Criteria
Inclusion Criteria: * Adults with polycythemia vera, essential thrombocythemia, or pre-myelofibrosis. * Indication for first-line treatment with hydroxyurea or pegylated interferon. * Consent to participate. * Affiliated to social security. Exclusion Criteria: * Previous treatment. * Other on-going malignancy, including overt myelofibrosis. * Other treatment such as phlebotomy solely, ruxolitinib, anagrelide, or pipobroman.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05440838 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Myeloproliferative Neoplasm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05440838 currently recruiting?
Yes, NCT05440838 is actively recruiting participants. Contact the research team at Corentin.Orvain@chu-angers.fr for enrollment information.
Where is the NCT05440838 trial being conducted?
This trial is being conducted at Angers, France, Brest, France, Nantes, France, Poitiers, France and 2 additional locations.
Who is sponsoring the NCT05440838 clinical trial?
NCT05440838 is sponsored by University Hospital, Angers. The trial plans to enroll 120 participants.