Myelodysplastic SyndromeNCT01331603
Assessment of Labile Plasma Iron (LPI) in Myelodysplastic Syndromes (MDS) and Primary Myelofibrosis
An observational study of Myelodysplastic Syndrome and Primary Myelofibrosis, run by Wolfson Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelodysplastic Syndrome, Primary Myelofibrosis
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2011to Jan 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- age > 18 years old
- MDS patients (low and high risk )
Who cannot join
- age < 18 years old
Trial locations and contacts
1 site in 1 country.
Israel1 site
Wolfson Medical Center
Holon
Ghoti Hussam, MD, 970-35028110, drghoti123@yahoo.com
About this study
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.
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.
Read the 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)
- Conditions
- Myelodysplastic Syndrome, Primary Myelofibrosis
- Keywords
- MDS, primary myelofibrosis, low+high risk MDS patients, patients
- Medical subject headings
- Myelodysplastic Syndromes, Primary Myelofibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2011 (estimated)
- Study startMar 2011
- Primary completionJan 2013 (estimated)
- Study completionJan 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelodysplastic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wolfson Medical Center
- Sponsor type
- Other government
- Investigators
- Ghoti Hussam, MD, Principal investigator, Hematolgy Department of Wolfson Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01331603
- Sponsor's protocol ID
- LPI1CTIL
- Status last verified
- Mar 2011
- First submitted
- 18 Jan 2011
- Last updated
- 8 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01331603
- Acronym / sponsor ID
- LPI1CTIL
- Conditions
- Myelodysplastic Syndrome, Primary Myelofibrosis
- Keywords
- MDS, primary myelofibrosis, low+high risk MDS patients, patients
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Wolfson Medical CenterOther government
- Study start
- Mar 2011
- Primary completion
- Jan 2013 (estimated)
- Study completion
- Jan 2013 (estimated)
- First posted
- 8 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (2 listed)
- age > 18 years old
- MDS patients (low and high risk )
Key exclusion criteria (1 listed)
- age < 18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The value of Ferritin,Transferrin Saturation,CRP and LPI at the blood samples
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ghoti Hussam, MD principal investigator
Hematolgy Department of Wolfson Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myelodysplastic Syndrome and Primary Myelofibrosis, run by Wolfson Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ghoti Hussam, MD (: 970-35028110, drghoti123@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The value of Ferritin,Transferrin Saturation,CRP and LPI at the blood samples (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2011.