Investigation of the value of bonemarrow stimulation in the diagnostic proces of patients with excess red/white bloodcells and platelets.

Investigation of the value of Iron and Bonemarrow stimulation in differential diagnostic of Polycythemia Vera and Essential Thrombocytosis

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-003276-39-DK

Enrollment

Registered

2012-08-29

Start date

2013-01-09

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycythemia Vera Essential thrombocytosis MedDRA version: 15.0 Level: HLGT Classification code 10022958 Term: Iron and trace metal metabolism disorders System Organ Class: 10027433 - Metabolism and nutrition disorders MedDRA version: 15.0 Level: HLT Classification code 10029355 Term: Neutropenias System Organ Class: 10005329 - Blood and lymphatic system disorders

Interventions

Trade Name: Ferro Duretter Product Name: ferro duretter Pharmaceutical Form: Tablet Trade Name: Neupogen Product Name: Neupogen Pharmaceutical Form: Solution for injection in pre-filled pen

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria: 1.Age> 18 years. 2.No cytoreductive therapy Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: 1. Pregnant women. 2. No Patient acceptance.

Design outcomes

Primary

Measure	Time frame
Main Objective: 1. To evaluate the diagnostic value of iron stimulation in differential diagnostic of JAK2V617F-positive and JAK2617F-negativ ET. 2. to evaluate the capacity to mobilise neutrofil cells in patients refered with high blood count and high number of platelets ;Secondary Objective: Secundary 1. To evaluate the relationship between neutrofil cell mobilisation capacity and JAK2-V617F- mutation level as assesed by quantitativ PCR-tecnique in full blood before and after rhG-CSF in patients with PV, ET and secundary polycythemia. 2. To investigate the correlation between the expression of alkaline phosphatase in granulocytes and JAK2V617F mutation burden before and after rhG-CSF in patients with PV, ET and secondary polycythemia. 3. To describe gene expression (full blood) before and after G-CSF stimulation in patients with ET, secondary polyglobuli and PV. 4. To describe the marker profile determined by flow cytometry on peripheral blood before and after the G-CSF stimulation. ;Primary end point(s): Ensure proper early diagnosis of myeloproliferative neoplasms ;Timepoint(s) of evaluation of this end point: In 3 years 2015	—

Measure

Time frame

Main Objective: 1. To evaluate the diagnostic value of iron stimulation in differential diagnostic of JAK2V617F-positive and JAK2617F-negativ ET. 2. to evaluate the capacity to mobilise neutrofil cells in patients refered with high blood count and high number of platelets ;Secondary Objective: Secundary 1. To evaluate the relationship between neutrofil cell mobilisation capacity and JAK2-V617F- mutation level as assesed by quantitativ PCR-tecnique in full blood before and after rhG-CSF in patients with PV, ET and secundary polycythemia. 2. To investigate the correlation between the expression of alkaline phosphatase in granulocytes and JAK2V617F mutation burden before and after rhG-CSF in patients with PV, ET and secondary polycythemia. 3. To describe gene expression (full blood) before and after G-CSF stimulation in patients with ET, secondary polyglobuli and PV. 4. To describe the marker profile determined by flow cytometry on peripheral blood before and after the G-CSF stimulation. ;Primary end point(s): Ensure proper early diagnosis of myeloproliferative neoplasms ;Timepoint(s) of evaluation of this end point: In 3 years 2015

—

Secondary

Measure	Time frame
Secondary end point(s): A certain separation of the disease entities will have great therapeutic impact because patients with early myelofibrosis probably will be treated early with interferon-alpha2 in the near future. ;Timepoint(s) of evaluation of this end point: In three years 2015	—

Countries

Denmark

Contacts

Public ContactHæmatologisk Afdeling

Region Sjælland

hkhl@regionsjaelland.dk

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026