Ignite Creation Date:
2025-12-24 @ 10:15 PM
Ignite Modification Date:
2026-03-02 @ 4:01 PM
Study NCT ID:
NCT01201135
Status:
UNKNOWN
Last Update Posted:
2010-09-14
First Post:
2010-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
GDF 15 in Sickle Cell Disease and Hereditary Spherocytosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000742', 'term': 'Anemia, Dyserythropoietic, Congenital'}], 'ancestors': [{'id': 'D000745', 'term': 'Anemia, Hemolytic, Congenital'}, {'id': 'D000743', 'term': 'Anemia, Hemolytic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-09', 'completionDateStruct': {'date': '2011-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-09-12', 'studyFirstSubmitDate': '2010-09-12', 'studyFirstSubmitQcDate': '2010-09-12', 'lastUpdatePostDateStruct': {'date': '2010-09-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'GDF 15', 'timeFrame': 'year'}], 'secondaryOutcomes': [{'measure': 'Hepcidine', 'timeFrame': 'year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Patients With Thalassemia Intermedia,', 'Congenital Dyserythropoietic Anemia Type I']}, 'descriptionModule': {'briefSummary': 'Patients with thalassemia intermedia, congenital dyserythropoietic anemia type I , and sideroblastic anemia were found to express very high levels of serum GDF15, and this contributed to the inappropriate suppression of hepcidin with subsequent secondary iron overload.The aim of our present study is to asses the levels of GDF15 and hepcidin in patients with Sickle cell disease and hereditary spherocytosis', 'detailedDescription': 'The identification of the ferroportin/hepcidin axis has allowed the effect of erythroid activity on iron balance to be studied and has created the basis for better defining the erythroid regulators.\n\nIn iron-loading anemias, ineffective erythropoiesis suppresses hepcidin production, which result in dysregulating iron homeostasis. Miller and co-workers showed that release of cytokines like growth differentiation factor 15 (GDF15) during the process of ineffective erythropoiesis inhibits hepcidin production, thus defining a molecular link between ineffective erythropoiesis, suppression of hepcidin production and parenchymal iron loading.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '5 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study will contain 40 patients with Sickle cell disease and 40 patients with hereditary spherocytosis.\n\nAfter ICF (Informed Consent Form) has been signed by the patients the following laboratory tests will be taken once during the study:\n\n1. GDF 15( 3ml of serum) (at the laboratory of hematology at Wolfson Medical Center/Israel)\n2. Hepcidine (3ml of serum) (at the laboratory of Prof. T. Ganz, USA). The blood samples should be taken at least one week apart from blood transfusion.\n\nIn case of infection or acute inflammation , blood samples should be taken only one week after resolution of these conditions.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* non\n\nExclusion Criteria:\n\n* non'}, 'identificationModule': {'nctId': 'NCT01201135', 'acronym': 'GDF 15', 'briefTitle': 'GDF 15 in Sickle Cell Disease and Hereditary Spherocytosis', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Wolfson Medical Center'}, 'officialTitle': 'The Impact of Growth Differentiating Factor (GDF) 15 in Sickle Cell Disease and Hereditary Spherocytosis', 'orgStudyIdInfo': {'id': 'GDF-15CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Sickle cell disease'}, {'label': 'hereditary spherocytosis.'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ghoti Hossam, doctor', 'role': 'CONTACT', 'email': 'drghoti123@yahoo.com', 'phone': '035028110'}], 'overallOfficials': [{'name': 'GHOTI HOSSAM, doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'HEMATOLOGY DEPARTMENT ON WOLFSSON MEDICAL CENTER'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wolfson Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': "Dr' Ghoti Hossam", 'oldOrganization': 'hematology department on Wolfsson Medical Center'}}}}