|- candidate number||9810|
|- NTR Number||NTR2951|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||23-jun-2011|
|- Secondary IDs||2011/122 CMO Arnhem-Nijmegen|
|- Public Title||IJzerstapeling bij patiŽnten met MDS: De waarde van nieuwe ijzerparameters en MRI als voorspeller van ijzerstapeling.|
|- Scientific Title||Iron overload in MDS patients: The value of new iron parameters and MRI T2* of heart and liver as predictor of iron overload.|
|- hypothesis||The hypothesis to be tested is the relationship between the number of blood transfusions, serum ferritin and transferrin saturation level and MRI T2*Heart, T2*Liver.|
|- Healt Condition(s) or Problem(s) studied||Myelodysplastic syndrome (MDS)|
|- Inclusion criteria||1. Patients with MDS according to WHO 2001-criteria (RA, RARS, RAEB-1, RAEB-2, RCMD, RCMD-RS, MDS with isolated del(5q), MDS-U);|
2. Patient with IPSS low-risk, intermediate-1 or intermediate-2 risk;
3. Untreated patients or patients treated with blood transfusions, growth factors, iron chelation therapy, the immunomodulatory drug lenalidomide or the hypomethylating agents azacitidine or decitabine;
4. Informed consent and of legal age at the time of obtaining informed consent (≥18yrs).
|- Exclusion criteria||1. Patients with previous intensive anti-leukemic therapy (intensive chemotherapy and/or stem cell transplantation);|
2. Patients with secondary or therapy-related AML and MDS after chemotherapy for a malignancy or radiotherapy;
3. Patients with IPSS high risk MDS;
4. Patients with a contraindication for MRI: Gadolinium allergy, impaired kidney function (MDRD <45 mL/min/1.73m2), metal parts, internal defibrillator, pacemaker, neurostimulator, bladder stimulator, insulin pump, cochlear implant, claustrophobia or another reason that prohibits MRI evaluation.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||1-jul-2011|
|- planned closingdate||1-jul-2017|
|- Target number of participants||75|
|- Interventions||No interventions.|
|- Primary outcome||A relationship between T2*Liver and or T2*Heart levels and the number of blood transfusions.|
|- Secondary outcome||Evidence for iron overload in transfusion-independent and transfusion-dependent MDS patients due to ineffective erythropoiesis.|
|- Timepoints||1. At inclusion;|
2. During follow-up: Every 6 months.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||MD. PhD. M. MacKenzie|
|- CONTACT for SCIENTIFIC QUERIES||MD. PhD. M. MacKenzie|
|- Sponsor/Initiator ||University Medical Center Nijmegen|
(Source(s) of Monetary or Material Support)
|- Brief summary||This is a prospective study in MDS patients with IPSS low-risk, intermediate-1 or intermediate-2 risk. Information will be gathered at the entry of the study and during follow-up visits scheduled for routine patient care.
To evaluate the relationship between red blood cell transfusions and iron overload in liver and heart as investigated by MRI T2* in MDS patients.
To evaluate the relationship between the iron parameters (serum ferritin and transferrin saturation level) and iron overload as investigated by MRI T2* in blood transfusion-dependent MDS patients.
To determine evidence for iron overload in transfusion-independent MDS patients due to ineffective erythropoiesis (serum iron, serum ferritin, transferrin saturation level, hepcidin, GDF15, sTfR and MRI T2*).
To determine evidence for iron overload in blood transfusion dependent MDS patients due to ineffective erythropoiesis (serum iron, serum ferritin, transferrin saturation level, hepcidin, GDF15, sTfR and MRI T2*).
To evaluate the effect of iron chelation therapy on the iron parameters and iron overload as investigated by MRI T2* (liver and heart) and to determine the best cut-off point to start iron chelation therapy.
To evaluate the relationship between the left ventricular diastolic function by echocardiography and iron overload in blood (serum iron, serum ferritin, transferrin saturation level, hepcidin, GDF15, sTfR) and iron overload as investigated by MRI T2*.
To determine if the presence of the HFE gene mutation has any influence on the severity of iron overload.
3 years inclusion, 3 years of follow-up per patient.
|- Main changes (audit trail)|
|- RECORD||23-jun-2011 - 3-jul-2011|