Myelodysplastic SyndromeNCT02262312
Iron Overload and Transient Elastography in Patients With Myelodysplastic Syndrome
An observational study of Myelodysplastic Syndrome, run by Zealand University Hospital at 1 site in Denmark.
Trial summary
Patients with myelodysplastic syndrome (MDS) have an ineffective hemopoiesis and often suffer from anemia. This can lead to red blood cell transfusion dependency and iron overload. Iron overload can affect the liver and lead to liver fibrosis and worst case cirrhosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelodysplastic Syndrome
- What is being tested?
- Transient elastography
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2014to Jun 2015
- 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: Patients with myelodysplastic syndrome among these include also patients with chronic myelomonocytic leukemia with myelodysplasia, patients with acute myeloid leukemia progressed from myelodysplastic syndrome and patients with myelodysplastic/myeloproliferative neoplasm, unclassifiable.
Who may be able to join
- Patients with a bone marrow describing myelodysplasia
- Among these:
- Patients with myelodysplastic syndrome (MDS)
- Patients with acute myeloid leukemia (AML) transformed from MDS
- Patients with chronic myelomonocytic leukemia (CMML) with dysplasia
- Patients with myelodysplastic/myeloproliferative neoplasm, unclassifiable
Who cannot join
- Body mass index (BMI) of 30 or higher than 30
- History with other known liver diseases
- Among these:
- Patients with chronic viral hepatitis C infection
- Patients with chronic viral hepatitis B infection
- Patients with alcoholic liver cirrhosis
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of hematology Roskilde hospital
Roskilde, Roskilde, DK-4000
About this study
Patients with myelodysplastic syndrome (MDS) have an ineffective hemopoiesis and often suffer from anemia. This can lead to red blood cell transfusion dependency and iron overload. Iron overload can affect the liver and lead to liver fibrosis and worst case cirrhosis. Ferritin is usually used to monitor the iron overload. In this study MDS patients will have a transient elastography performed which measures the liver's stiffness. The purpose is to investigate whether liver stiffness measurements are coherent to ferritin levels.
Read the detailed description
Transient elastography is noninvasive and has no side effects. No liver biopsy will be performed due to serious side-effects and risks in this patientgroup.
The results of the transient elastography will be compared to the patient's ferritin levels and the numbers of months the patients have had MDS to find out if there is a correlation. Furthermore we will compare the liver stiffness measurements in the patients with higher ferritin levels to those who have lower ferritin levels. We will also compare the liver stiffness measurements in patients who are red blood cell transfusion dependent compared to those who are red blood cell transfusion independent. We will also compare liver stiffness measurements in the patients with a high alanine aminotransferase (ALAT) compared to those with normal ALAT.
- Conditions
- Myelodysplastic Syndrome
- Being tested
- Transient elastography
- Medical subject headings
- Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transient elastographyOther
Also called Fibroscan, Liver stiffness measurements
All patients will have a transient elastography performed as a measure of liver stiffness.
| Study group | Role | What they receive |
|---|---|---|
| Patients with myelodysplastic syndrome | Patients with myelodysplastic syndrome among these include also patients with chronic myelomonocytic leukemia with myelodysplasia, patients with acute myeloid leukemia progressed from myelodysplastic syndrome and patients with myelodysplastic/myeloproliferative neoplasm, unclassifiable Receives: Other: Transient elastography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver stiffness
Liver stiffness is measured in kilopascal (kPa)
Measured: Transient elastography (Fibroscan) 5 minutes
Iron overload: Ferritin
Ferritin is measured in micrograms per liter
Measured: Blood samples 5 minutes
Secondary outcomes (3)
Disease period
Period of disease will be calculated in months
Measured: Information regarding time of diagnosis will be obtained retrospectively
Red blood cell transfusion dependency
Transfusion dependency will be defined as having at least one red blood cell transfusion every other eight weeks over a period of four months prior to the date of the fibroscan. Red blood cell dependency will be either "yes" or "no"
Measured: Information regarding transfusion will be obtained retrospectively
Liver inflammation: Alanine aminotransferase
Alanine aminotransferase is measured in units per liter
Measured: Blood samples 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2014 (estimated)
- Study startSep 2014
- Primary completionJun 2015
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.
- More trials run by Zealand University HospitalThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Klas Raaschou-Jensen, Principal investigator, Consultant at department of hematology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02262312
- Sponsor's protocol ID
- SJ-402
- Status last verified
- Jun 2015
- First submitted
- 18 Sep 2014
- Last updated
- 9 Jun 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iron Overload and Transient Elastography in Patients With Myelodysplastic Syndrome
- ClinicalTrials.gov ID
- NCT02262312
- Acronym / sponsor ID
- SJ-402
- Conditions
- Myelodysplastic Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Jun 2015 (actual)
- First posted
- 13 Oct 2014 (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.
Patients with myelodysplastic syndrome (MDS) have an ineffective hemopoiesis and often suffer from anemia. This can lead to red blood cell transfusion dependency and iron overload. Iron overload can affect the liver and lead to liver fibrosis and worst case cirrhosis. Ferritin is usually used to monitor the iron overload. In this study MDS patients will have a transient elastography performed which measures the liver's stiffness. The purpose is to investigate whether liver stiffness measurements are coherent to ferritin levels.
Detailed description
Transient elastography is noninvasive and has no side effects. No liver biopsy will be performed due to serious side-effects and risks in this patientgroup.
The results of the transient elastography will be compared to the patient's ferritin levels and the numbers of months the patients have had MDS to find out if there is a correlation. Furthermore we will compare the liver stiffness measurements in the patients with higher ferritin levels to those who have lower ferritin levels. We will also compare the liver stiffness measurements in patients who are red blood cell transfusion dependent compared to those who are red blood cell transfusion independent. We will also compare liver stiffness measurements in the patients with a high alanine aminotransferase (ALAT) compared to those with normal ALAT.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with myelodysplastic syndrome | – | Other: Transient elastographyPatients with myelodysplastic syndrome among these include also patients with chronic myelomonocytic leukemia with myelodysplasia, patients with acute myeloid leukemia progressed from myelodysplastic syndrome and patients with myelodysplastic/myeloproliferative neoplasm, unclassifiable |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with myelodysplastic syndrome among these include also patients with chronic myelomonocytic leukemia with myelodysplasia, patients with acute myeloid leukemia progressed from myelodysplastic syndrome and patients with myelodysplastic/myeloproliferative neoplasm, unclassifiable.
Key inclusion criteria (6 listed)
- Patients with a bone marrow describing myelodysplasia
- Patients with myelodysplastic syndrome (MDS)
- Patients with acute myeloid leukemia (AML) transformed from MDS
- Patients with chronic myelomonocytic leukemia (CMML) with dysplasia
- Patients with myelodysplastic/myeloproliferative neoplasm, unclassifiable
Key exclusion criteria (6 listed)
- Body mass index (BMI) of 30 or higher than 30
- History with other known liver diseases
- Patients with chronic viral hepatitis C infection
- Patients with chronic viral hepatitis B infection
- Patients with alcoholic liver cirrhosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transient elastographyAlso: Fibroscan, Liver stiffness measurementsAll patients will have a transient elastography performed as a measure of liver stiffness. | Other | Patients with myelodysplastic syndrome |
Primary outcome
Liver stiffness
Time frame: Transient elastography (Fibroscan) 5 minutes
Liver stiffness is measured in kilopascal (kPa)
Iron overload: Ferritin
Time frame: Blood samples 5 minutes
Ferritin is measured in micrograms per liter
3 secondary outcomes
Disease period
Time frame: Information regarding time of diagnosis will be obtained retrospectively
Red blood cell transfusion dependency
Time frame: Information regarding transfusion will be obtained retrospectively
Liver inflammation: Alanine aminotransferase
Time frame: Blood samples 5 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2015.
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ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS
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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.
Klas Raaschou-Jensen principal investigator
Consultant at department of hematology
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, run by Zealand University Hospital at 1 site in Denmark.
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 6 inclusion and 6 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: finished, as of the sponsor's last update on 9 Jun 2015. 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 Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liver stiffness (time frame: Transient elastography (Fibroscan) 5 minutes). The study lists 2 primary outcomes in all. 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 9 Jun 2015.