Functional and Phenotypic Characterization of Monocytes in Myeloproliferative Syndromes
PHEMOP
2 other identifiers
interventional
70
1 country
3
Brief Summary
Prospective study for functional and phenotypic characterization of monocytes in philadelphia-negative myeloproliferative neoplasms
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2024
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 12, 2024
CompletedFirst Posted
Study publicly available on registry
April 12, 2024
CompletedStudy Start
First participant enrolled
May 29, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 19, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 19, 2028
December 8, 2025
December 1, 2025
2.4 years
March 12, 2024
December 2, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
WHO 2016 criteria for polycythemia vera, prefibrotic myelofibrosis, essential thrombocytosis and overt myelofibrosis diagnosis
Assessment of the monocytic signature against the WHO diagnosis (AUC will be determined)
Day 0
Secondary Outcomes (7)
Identify correlation between the monocytic signature and driver mutations (mutation in JAK2, CALR or MPL gene).
24 months
Identify correlation between the monocytic signature and the grade of fibrosis
24 months
prognostic value of the monocytic signature using a principal component analysis Response criteria according to Barosi et al., Leukemia, vol. 29,1 (2015): 20-6
12, 24 months
Prognostic value of the monocyte signature for disease worsening according to Sureau et al., Blood Cancer Journal, vol. 12,4, 56. 8 Apr. 2022
24 months
leukemia-free survival
24 months
- +2 more secondary outcomes
Study Arms (1)
Phemop Cohort
EXPERIMENTALInterventions
The monocytes signatures will be perform from a peripheral blood sample. The signature will be derived from (i) surface marker expression, (ii) cytokines profiles, (iii) genes expression.
Eligibility Criteria
You may qualify if:
- Diagnosis of PV, ET, pre-myelofibrosis or primary myelofibrosis according to WHO 2022 criteria (including BOM for ET, premyelofibrosis and primary myelofibrosis)
- Patient who has not received treatment specific to hemopathy at the time of sampling
- Obtaining the signature of consent to participate in the study
- Patient having consented to be included in the "Malignant Hemopathy" collection of Angers University Hospital and in FIMBANK database
You may not qualify if:
- Person not affiliated to a social security scheme or beneficiary of such a scheme
- Patient with another hemopathy or another active cancer at the time of diagnosis
- Minor patient at diagnosis (\< 18 years old)
- Patient not capable or without agreement from the guardian or legal representative
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
GOUBAND Agathe
Angers, Maine et Loire, 49933, France
BESCOND Charles
Cholet, Maine et Loire, 49325, France
TRUCHAN-GRACZYK Malgorzata
Saumur, Maine et Loire, 49400, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Agathe GOUBAND, PharmD
University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 12, 2024
First Posted
April 12, 2024
Study Start
May 29, 2024
Primary Completion (Estimated)
October 19, 2026
Study Completion (Estimated)
October 19, 2028
Last Updated
December 8, 2025
Record last verified: 2025-12