Assessment of Labile Plasma Iron (LPI) in Myelodysplastic Syndromes (MDS) and Primary Myelofibrosis

• Conditions: Myelodysplastic Syndrome; Primary Myelofibrosis

• Registration Number: NCT01331603
• Lead Sponsor: Wolfson Medical Center

Brief Summary

Recently, it has been demonstrated that iron overload is associated with the appearance of labile plasma iron (LPI).

LPI is redox active and is rapidly taken up by cells, leading to a rise in the labile iron pool (LIP) and catalyzing generation of reactive oxygen species (ROS), which can lead to cellular damage.

The LPI data are mostly derived from thalassemia iron overload research , however, there are a few data describing LPI and its correlations with the classical iron overload parameters (ferritin, TSAT) in acute anemias such as MDS Therefore we are going to assess LPI in iron overloaded myelodysplastic syndromes (MDS) (low and high risk) and primary myelofibrosis, in order to assess whether it can be used as alternative to the routinely used parameters; TSAT and ferritin levels.

Detailed Description

Approximately 60-80% of patients with myelodysplastic syndromes (MDS) present with symptomatic anemia and 80-90%, of these, will require red blood cell (RBC) transfusions. Excess transfusional iron causes iron overload (IO) which is characterized by elevated serum ferritin (\> 1000ng/ml) and transferrin saturation (TSAT \> 50%) levels.

Assessment of IO using serum ferritin and TSAT levels is not accurate enough and this is due to changes in serum ferritin and TSAT during any inflammatory condition.

Since serum ferritin is considered as a positive acute phase reactant and therefore inflammatory state can lead to an increase in serum ferritin levels and so does not reflect the exact amount of iron overload.

In contrast TSAT can decrease during inflammation and in addition it follows diurnal variations.The aim of our present study is to asses the levels of LPI in patients with in iron overloaded MDS patients (low and high risk), and also patients with primary myelofibrosis, in order to find out any laboratory correlations between LPI, TSAT and srum ferritin levels.

Methods:

The study will contain 50 patients low+high risk MDS patients and patients with primary myelofibrosis with iron overloaded. The risk stratification of these patients will be calculated according to the WPSS (WHO adapted Prognostic Scoring System)

After ICF (Informed Consent Form) has been signed by the patients the following laboratory tests will be taken once during the study:

* Ferritin (local laboratory)

* Transferrin Saturation (local laboratory)

* CRP (local laboratory)

* LPI (feROS™ eLPI from Aferrix Ltd., Tel- Aviv, Israel)

Study Timeline

• Study First Submitted: 2011-01-18
• Status Verified: 2011-03
• Study Start: 2011-03
• Study First Submitted QC: 2011-04-07
• Last Update Submitted: 2011-04-07
• Study First Posted: 2011-04-08
• Last Update Posted: 2011-04-08
• Primary Completion: 2013-01
• Study Completion: 2013-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• age > 18 years old
• MDS patients (low and high risk )

Exclusion Criteria

• age < 18 years old

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The value of Ferritin,Transferrin Saturation,CRP and LPI at the blood samples	1 year	The blood samples should be taken at least one week apart from last blood transfusion.; In case of infection or acute inflammation , blood samples should be taken only one week after resolution of these conditions.

Trial Locations

Locations (1)

Wolfson Medical Center; 🇮🇱 Holon,, Israel