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

Assessment of Labile Plasma Iron (LPI) as an Alternative Parameter for Iron Overload in MDS and Primary Myelofibrosis Patients With Iron Overload and Its Correlations With the Classical Iron Overload Parameters.

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.

Study Overview

• Status: Unknown
• Conditions: Primary Myelofibrosis; Myelodysplastic Syndrome

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 Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Ghoti Hussam, MD; Phone Number: : 970-35028110; Email: drghoti123@yahoo.com

Study Locations

• Israel
  • Holon,, Israel
    • Wolfson Medical Center
    • Contact: Ghoti Hussam, MD; Phone Number: 970-35028110; Email: drghoti123@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

low and high risk MDS patients and primary myelofibrosis patients.The risk stratification of these patients will be calculated according to the WPSS (WHO adapted Prognostic Scoring System)

Description

Inclusion Criteria:

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

Exclusion Criteria:

• age < 18 years old

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
MDS and primary myelofibrosis patients; patients with in iron overloaded MDS patients (low and high risk ), and also patients with primary myelofibrosis. The risk stratification of these patients will be calculated according to the IPSS (International Prognostic Scoring System).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The value of Ferritin,Transferrin Saturation,CRP and LPI at the blood samples	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.	1 year

Collaborators and Investigators

• Sponsor: Wolfson Medical Center
• Investigators: Principal Investigator: Ghoti Hussam, MD, Hematolgy Department of Wolfson Medical Center

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Anticipated): January 1, 2013
• Study Completion (Anticipated): January 1, 2013

Study Registration Dates

• First Submitted: January 18, 2011
• First Submitted That Met QC Criteria: April 7, 2011
• First Posted (Estimate): April 8, 2011

Study Record Updates

• Last Update Posted (Estimate): April 8, 2011
• Last Update Submitted That Met QC Criteria: April 7, 2011
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Keywords: patients; primary myelofibrosis; MDS; low+high risk MDS patients
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Disease; Bone Marrow Diseases; Hematologic Diseases; Myeloproliferative Disorders; Precancerous Conditions; Syndrome; Myelodysplastic Syndromes; Primary Myelofibrosis; Preleukemia
• Other Study ID Numbers: LPI1CTIL