Incidence of Iron Deficiency in Polycythemia Vera (PV) and Association With Disease Features

NCT02809274 | Unknown DMC

• 1 other identifier: 0186-16 CTIL
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 12

Brief Summary

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

Polycythemia Vera

Keywords

iron deficiency; polycythemia vera

Outcome Measures

Primary Outcomes (1)

• Incidence of iron deficiency in patients with PV

  2 years

Secondary Outcomes (4)

• Association between iron deficiency and other clinical features

  2 years

• Influence of therapy (phlebotomies, hydroxyurea, other therapies) on iron parameters

  2 years

• Influence of iron parameters on Patient-reported symptoms

  2 years

• Influence of iron deficiency on arterial and venous thrombosis rate

  2 years

Study Arms (2)

Patients with PV, not newly diagnosed

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

Other: questionnaires

Newly diagnosed patients with PV

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

Other: questionnaires

Interventions

questionnaires OTHER

• Influence of iron parameters on Patient-reported symptoms as assessed by Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS) for assessment of the severity of symptoms, Quality of life evaluation by The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) and fatigue assessment by PROMIS Fatigue Scale: Short Form

Newly diagnosed patients with PV; Patients with PV, not newly diagnosed

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

An adult population (patients \>18 years old) of men and women who have been diagnosed with clinically overt PV will be enrolled. Sites will include both community and academic centers across Isreal.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rambam Health Care Campus: lead
• Meir Medical Center: collaborator

Study Sites (12)

Emek Medical center

Afula, Israel

Location

Soroka medical center

Beersheba, Israel

Location

Hillel Yaffe Medical Center

Hadera, Israel

Location

Bnei Zion medical center

Haifa, Israel

Location

Rambam Medical center

Haifa, Israel

Location

Meir Medical center

Kfar Saba, Israel

Location

Sheba medical center

Ramat Gan, Israel

Location

Kaplan medical center

Rehovot, Israel

Location

Ziv Medical center

Safed, Israel

Location

Maccabi

Tel Aviv, Israel

Location

Tel Aviv Sourasky

Tel Aviv, Israel

Location

Assaf Harofeh Medical Center

Ẕerifin, Israel

Location

Related Publications (6)

• Pearson 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 BACKGROUND

• Hutton 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 BACKGROUND

• Kwapisz 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 BACKGROUND

• Rector 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 BACKGROUND

• Franchini 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 BACKGROUND

• Birgegard 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 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum blood sample for hepcidin

MeSH Terms

Conditions

Polycythemia Vera; Iron Deficiencies

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Bone Marrow Neoplasms; Hematologic Neoplasms; Neoplasms by Site; Neoplasms; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Myeloproliferative Disorders; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Noa Lavi, Dr

  Rambam Health Care Campus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Noa Lavi, Dr

CONTACT

972-50-2061332; lavi.noa@gmail.com

Martin Ellis, Prof.

CONTACT

972-53-7482482; martinel@clalit.org.il

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: June 18, 2016
• First Posted: June 22, 2016
• Study Start: July 1, 2016
• Primary Completion: July 1, 2018
• Study Completion: August 1, 2018
• Last Updated: June 22, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

IL (12)