Ignite Creation Date:
2025-12-24 @ 6:42 PM
Ignite Modification Date:
2026-02-23 @ 12:22 PM
Study NCT ID:
NCT02855957
Status:
COMPLETED
Last Update Posted:
2016-08-04
First Post:
2016-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Free α-hemoglobin Pool in the Red Blood Cells : Prognostic Marker and Severity Index in Thalassemic Syndromes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013789', 'term': 'Thalassemia'}], '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': 'D006453', 'term': 'Hemoglobinopathies'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 135}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-31', 'studyFirstSubmitDate': '2016-07-31', 'studyFirstSubmitQcDate': '2016-07-31', 'lastUpdatePostDateStruct': {'date': '2016-08-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-08-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation between the pool of free α-Hb and genotype α and β -globin of the patient and if necessary with the genotype AHSP gene', 'timeFrame': 'Day 1'}], 'secondaryOutcomes': [{'measure': 'Correlation between the pool of free α-Hb and Hb value', 'timeFrame': 'Day 1'}, {'measure': 'Correlation between the pool of free α-Hb and Mean Corpuscular Hb', 'timeFrame': 'Day 1'}, {'measure': 'Correlation between the pool of free α-Hb and Mean Cell Volume', 'timeFrame': 'Day 1'}, {'measure': 'Correlation between the pool of free α-Hb and percent of reticulocytes', 'timeFrame': 'Day 1'}, {'measure': 'Correlation between the pool of free α-Hb and fetal Hb', 'timeFrame': 'Day 1'}, {'measure': 'Correlation between the pool of free α-Hb and erythrocyte enzymes', 'timeFrame': 'Day 1'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Alpha-Hemoglobin Stabilizing Protein', 'alpha-Hb pool', 'thalassemias', 'diagnostic method', 'biomarker'], 'conditions': ['Thalassemic Syndromes']}, 'referencesModule': {'references': [{'pmid': '21264907', 'type': 'BACKGROUND', 'citation': 'Vasseur C, Pissard S, Domingues-Hamdi E, Marden MC, Galacteros F, Baudin-Creuza V. Evaluation of the free alpha-hemoglobin pool in red blood cells: a new test providing a scale of beta-thalassemia severity. Am J Hematol. 2011 Feb;86(2):199-202. doi: 10.1002/ajh.21918.'}]}, 'descriptionModule': {'briefSummary': 'Our project aims to assess and validate an innovative prognostic and diagnostic test in order to i) define a severity index of the β-thalassemia according to the free α-Hb pool for a better management of the patient; ii) differentiate the α-thalassemia and β-thalassemia and iii) follow the evolution of this pool in response to treatment of patients. In the future, this prognostic test based on the measurement of free α-Hb pool may be suitable for routine laboratory practice. To carry out this project, cohort of 85 thalassemic patients and a group of 50 healthy volunteers have been recruited.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria Patient\n\n* Age ≥ 18 years\n* Written informed consent\n* Affiliation to social security\n* Known Hb Phenotypes\n* Biological phenotype corresponding to a classical picture of thalassemia\n\nHealthy volunteers\n\n* Age ≥ 18 years\n* Written informed consent\n* Affiliation to social security\n\nExclusion Criteria Patient\n\n* Transfusion for less than 3 months\n* Chronic active viral disease: hepatitis B, C, HIV\n* Ongoing infections or known inflammatory diseases\n* Hyper or Hypothyroidism known or subject treated by Levothyrox\n* Active pathology or tumor remission for less than 5 years\n* Oral corticosteroid\n* Hemoglobinopathy other than thalassemia for patients\n* Treatment by Hydroxyurea for more than 3 months\n* Treatment by stimulating agent erythropoiesis for longer than 3 months\n\nHealthy volunteers\n\n* Transfusion for less than 3 months\n* Chronic active viral disease: hepatitis B, C, HIV\n* Ongoing infections or known inflammatory diseases\n* Hyper or Hypothyroidism known or subject treated by Levothyrox\n* Active pathology or tumor remission for less than 5 years\n* Oral corticosteroid\n* Genetically related to person with hemoglobinopathy'}, 'identificationModule': {'nctId': 'NCT02855957', 'acronym': 'ALPHAPOOL', 'briefTitle': 'Evaluation of the Free α-hemoglobin Pool in the Red Blood Cells : Prognostic Marker and Severity Index in Thalassemic Syndromes', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Evaluation of the Free α-hemoglobin Pool in the Red Blood Cells : Prognostic Marker and Severity Index in Thalassemic Syndromes', 'orgStudyIdInfo': {'id': 'P120205'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Blood sample', 'description': 'A blood collection is carry out in the three populations of patients during the day of their enrolment.', 'interventionNames': ['Other: Free α-Hb pool analysis']}], 'interventions': [{'name': 'Free α-Hb pool analysis', 'type': 'OTHER', 'armGroupLabels': ['Blood sample']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94010', 'city': 'Créteil', 'country': 'France', 'facility': 'Henri Mondor Hospital', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}], 'overallOfficials': [{'name': 'Frédéric Galacteros, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'Institut National de la Santé Et de la Recherche Médicale, France', 'class': 'OTHER_GOV'}, {'name': 'Paris 12 Val de Marne University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}