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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Wolfson Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Wolfson Medical Center
ClinicalTrials.gov Identifier:
NCT01331603
First received: January 18, 2011
Last updated: April 7, 2011
Last verified: March 2011
  Purpose

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.


Condition
Myelodysplastic Syndrome
Primary Myelofibrosis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
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.

Resource links provided by NLM:


Further study details as provided by Wolfson Medical Center:

Primary Outcome Measures:
  • The value of Ferritin,Transferrin Saturation,CRP and LPI at the blood samples [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

    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.



Estimated Enrollment: 50
Study Start Date: March 2011
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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).

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)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • age < 18 years old
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01331603

Contacts
Contact: Ghoti Hussam, MD : 970-35028110 drghoti123@yahoo.com

Locations
Israel
Wolfson Medical Center Not yet recruiting
Holon,, Israel
Contact: Ghoti Hussam, MD    970-35028110    drghoti123@yahoo.com   
Sponsors and Collaborators
Wolfson Medical Center
Investigators
Principal Investigator: Ghoti Hussam, MD Hematolgy Department of Wolfson Medical Center
  More Information

No publications provided

Responsible Party: Dr' Ghoti Hussam, Hematology department of Wolfson Medical Center
ClinicalTrials.gov Identifier: NCT01331603     History of Changes
Other Study ID Numbers: LPI1CTIL
Study First Received: January 18, 2011
Last Updated: April 7, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Wolfson Medical Center:
MDS
primary myelofibrosis
low+high risk MDS patients
patients

Additional relevant MeSH terms:
Primary Myelofibrosis
Myelodysplastic Syndromes
Preleukemia
Iron Overload
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms
Iron Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on April 17, 2014