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

Myelodysplastic Syndrome Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01331603
• Other study ID #: LPI1CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: January 18, 2011
• Last updated: April 7, 2011
• Start date: March 2011
• Est. completion date: January 2013

Study information

• Verified date: March 2011
• Source: Wolfson Medical Center
• Contact: Ghoti Hussam, MD
• Phone: : 970-35028110
• Email: drghoti123[@]yahoo.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age > 18 years old

• MDS patients (low and high risk )

Exclusion Criteria:

• age < 18 years old

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Myelodysplastic Syndrome
• Myelodysplastic Syndromes
• Preleukemia
• Primary Myelofibrosis

Locations

Country	Name	City	State
Israel	Wolfson Medical Center	Holon,

Sponsors (1)

Lead Sponsor	Collaborator
Wolfson Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes