Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2025-12-29 @ 11:40 PM
Study NCT ID:
NCT01331603
Status:
UNKNOWN
Last Update Posted:
2011-04-08
First Post:
2011-01-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Labile Plasma Iron (LPI) in Myelodysplastic Syndromes (MDS) and Primary Myelofibrosis
Sponsor:
Wolfson Medical Center
Organization:
Study Overview
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.
Status:
UNKNOWN
Status Verified Date:
2011-03
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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)
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: