Clinical trial · Observational
Incidence of Iron Deficiency in Polycythemia Vera (PV) and Association With Disease Features
NCT02809274CI-TRIAL-00022671unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Iron deficiency is a known feature of PV, occurs because of accelerated erythropoiesis, gastrointestinal blood loss and phlebotomy. Incidence and effect of iron deficiency in these patients is not well characterized. The study will assess the incidence of iron deficiency at diagnosis and during the course of PV, assess effect of iron deficiency on patient symptoms and its correlation with disease features. This is a multicenter, non-interventional, non-randomized, prospective, observational study in an adult population (patients \>18 years old) of patients who have been diagnosed with PV and are being followed in either community or academic medical centers in Israel.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Polycythemia Vera | Polycythemia Vera | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| questionnaires | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Patients with PV, not newly diagnosed
- description
- Patients with clinically overt PV treated with watchful waiting (with or without aspirin), Phlebotomy (PHL), Hydrea or any other treatment. Influence of iron parameters on Patient-reported symptoms will be evaluated by questionnaires Blood serum samples will be taken for iron parameters analysis
- interventionNames
- Other: questionnaires
- label
- Newly diagnosed patients with PV
- description
- Patients with clinically overt PV, newly diagnosed, before any treatment and before phlebotomy initiation. Influence of iron parameters on Patient-reported symptoms will be evaluated by questionnaires Blood serum samples will be taken for iron parameters analysis
- interventionNames
- Other: questionnaires
Primary outcomes (1)
- measure
- Incidence of iron deficiency in patients with PV
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥18 years * Diagnosis of Polycythemia Vera (PV) * Willing and able to provide written informed consent * Willing and able to complete patient assessment questionnaires either alone or with minimal assistance from a caregiver and/or trained site personnel * Under the supervision of a physician for the current care of PV including but not limited to watchful waiting, acetylsalicylic acid (ASA) 81mg or greater, antithrombotic therapy, Phlebotomy (PHL), Hydroxyurea (HU), interferon (recombinant or pegylated), busulfan, anagrelide Exclusion Criteria: * Diagnosis of myelofibrosis (MF) \[including primary MF, post-PV MF, or post-essential thrombocythemia MF (post-ET MF)\] * Diagnosis of secondary Acute Myeloid Leukemia (AML) * Diagnosis of Myelodysplastic Syndrome (MDS) * Splenectomy
References
Publications (6)
- BACKGROUNDPearson TC, Grimes AJ, Slater NG, Wetherley-Mein G. Viscosity and iron deficiency in treated polycythaemia. Br J Haematol. 1981 Sep;49(1):123-7. doi: 10.1111/j.1365-2141.1981.tb07205.x. PMID 7272225
- BACKGROUNDHutton RD. The effect of iron deficiency on whole blood viscosity in polycythaemic patients. Br J Haematol. 1979 Oct;43(2):191-9. doi: 10.1111/j.1365-2141.1979.tb03741.x. PMID 508628
- BACKGROUNDKwapisz J, Zekanowska E, Jasiniewska J. Decreased serum prohepcidin concentration in patients with polycythemia vera. J Zhejiang Univ Sci B. 2009 Nov;10(11):791-5. doi: 10.1631/jzus.B0920217. PMID 19882752
- BACKGROUNDRector WG Jr, Fortuin NJ, Conley CL. Non-hematologic effects of chronic iron deficiency. A study of patients with polycythemia vera treated solely with venesections. Medicine (Baltimore). 1982 Nov;61(6):382-9. doi: 10.1097/00005792-198211000-00004. No abstract available. PMID 7144531
- BACKGROUNDFranchini M, Targher G, Montagnana M, Lippi G. Iron and thrombosis. Ann Hematol. 2008 Mar;87(3):167-73. doi: 10.1007/s00277-007-0416-1. Epub 2007 Dec 8. PMID 18066546
- BACKGROUNDBirgegard G, Carlsson M, Sandhagen B, Mannting F. Does iron deficiency in treated polycythemia vera affect whole blood viscosity? Acta Med Scand. 1984;216(2):165-9. doi: 10.1111/j.0954-6820.1984.tb03788.x. PMID 6496176