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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}, {'id': 'D055728', 'term': 'Primary Myelofibrosis'}], 'ancestors': [{'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D009196', 'term': 'Myeloproliferative Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-03', 'completionDateStruct': {'date': '2013-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-04-07', 'studyFirstSubmitDate': '2011-01-18', 'studyFirstSubmitQcDate': '2011-04-07', 'lastUpdatePostDateStruct': {'date': '2011-04-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The value of Ferritin,Transferrin Saturation,CRP and LPI at the blood samples', 'timeFrame': '1 year', 'description': 'The blood samples should be taken at least one week apart from last blood transfusion.\n\nIn case of infection or acute inflammation , blood samples should be taken only one week after resolution of these conditions.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['MDS', 'primary myelofibrosis', 'low+high risk MDS patients', 'patients'], 'conditions': ['Myelodysplastic Syndrome', 'Primary Myelofibrosis']}, 'descriptionModule': {'briefSummary': 'Recently, it has been demonstrated that iron overload is associated with the appearance of labile plasma iron (LPI).\n\nLPI 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.\n\nThe 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.', 'detailedDescription': '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.\n\nAssessment 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.\n\nSince 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.\n\nIn 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.\n\nMethods:\n\nThe 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)\n\nAfter ICF (Informed Consent Form) has been signed by the patients the following laboratory tests will be taken once during the study:\n\n* Ferritin (local laboratory)\n* Transferrin Saturation (local laboratory)\n* CRP (local laboratory)\n* LPI (feROS™ eLPI from Aferrix Ltd., Tel- Aviv, Israel)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\> 18 years old\n* MDS patients (low and high risk )\n\nExclusion Criteria:\n\n* age \\< 18 years old'}, 'identificationModule': {'nctId': 'NCT01331603', 'briefTitle': 'Assessment of Labile Plasma Iron (LPI) in Myelodysplastic Syndromes (MDS) and Primary Myelofibrosis', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Wolfson Medical Center'}, 'officialTitle': '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.', 'orgStudyIdInfo': {'id': 'LPI1CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'MDS and primary myelofibrosis patients', 'description': '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).'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Holon', 'country': 'Israel', 'contacts': [{'name': 'Ghoti Hussam, MD', 'role': 'CONTACT', 'email': 'drghoti123@yahoo.com', 'phone': '970-35028110'}], 'facility': 'Wolfson Medical Center', 'geoPoint': {'lat': 32.01034, 'lon': 34.77918}}], 'centralContacts': [{'name': 'Ghoti Hussam, MD', 'role': 'CONTACT', 'email': 'drghoti123@yahoo.com', 'phone': ': 970-35028110'}], 'overallOfficials': [{'name': 'Ghoti Hussam, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hematolgy Department of Wolfson Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wolfson Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': "Dr' Ghoti Hussam", 'oldOrganization': 'Hematology department of Wolfson Medical Center'}}}}