Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-25 @ 9:17 PM
Study NCT ID:
NCT01648556
Status:
UNKNOWN
Last Update Posted:
2016-08-02
First Post:
2012-07-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Research of Predictive Factors to Immune Thrombopenic Purpura
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011696', 'term': 'Purpura, Thrombocytopenic'}], 'ancestors': [{'id': 'D011693', 'term': 'Purpura'}, {'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D057049', 'term': 'Thrombotic Microangiopathies'}, {'id': 'D013921', 'term': 'Thrombocytopenia'}, {'id': 'D001791', 'term': 'Blood Platelet Disorders'}, {'id': 'D000095542', 'term': 'Cytopenia'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006403', 'term': 'Hematologic Tests'}], 'ancestors': [{'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2018-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-08-01', 'studyFirstSubmitDate': '2012-07-20', 'studyFirstSubmitQcDate': '2012-07-20', 'lastUpdatePostDateStruct': {'date': '2016-08-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the result of cytogenetics medullary', 'timeFrame': 'two years after inclusion', 'description': 'the primary endpoint corresponds to the occurence of the PTI after two years after inclusion.'}], 'secondaryOutcomes': [{'measure': 'dosage of the TPO', 'timeFrame': 'EVERY 4 MONTHS (followed every four months during two years apres inclusion)'}, {'measure': 'the result to the antibodies antiplatelet (positive or negative) for MAIPA', 'timeFrame': 'EVERY 4 MONTHS (followed every 4 months during two years after the inclusion)'}, {'measure': 'The isotopic lifetime of platelet', 'timeFrame': 'EVERY 4 MONTHS (followed every four months during two years apres inclusion)', 'description': '\\< or \\> 3.5 days'}, {'measure': 'The test in corticoids by the prednisone per os', 'timeFrame': 'EVERY 4 MONTHS (followed every 4 months during two years after the inclusion)', 'description': '1 mg / kg / day for 3 weeks The therapeutic test is considered as positive if a number of platelets is \\> 50 G/l with at least a doubling of the platelet rate before treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Purpura thrombopenic', 'Medullary cytogenetics', 'Myelodysplasic syndrome', 'bone marrow biopsy'], 'conditions': ['Purpura Thrombopenic']}, 'descriptionModule': {'briefSummary': "It is about a multicentric study prospective of more than patients' 60 years with a thrombopenia isolated of less than 100 G/L blood platelet without cause found to estimate so certain examinations realized in the diagnosis (medullary cytogenetics, dosage of the TPO, the Anti-platelet antibodies, isotopic lifetime of platelet) are in favour of the diagnosis of PTI.", 'detailedDescription': "It is about a multicentric study prospective of more than patients' 60 years with a thrombopenia isolated of less than 100 G/L blood platelet without cause found to estimate so certain examinations realized in the diagnosis (medullary cytogenetics, dosage of the TPO, the Anti-platelet antibodies, isotopic lifetime of platelet) are in favour of the diagnosis of PTI.\n\nThe principal endpoint is to evaluate if the medullary cytogenetics is the predictive factor of the diagnosis of PTI in front of a thrombopenia isolated in elderly.\n\nThe secondary endpoints are :\n\n* to identify at the time of the diagnosis, the factors and/or predictive markers correlated in the final diagnosis of PTI or SMD\n* to study the respective frequency of the PTI and the SMD in front of a thrombopenia seemingly isolated of the subject of more than 60 years.\n\n 200 patients will be included. 160 patients should be assessable at the end of study by considering the excluded patients, the dead and the lost sight.They will be followed every 4 months, during two years.\n\nIn every visit, will be realized a clinical examination, a blood film, a haemogram.\n\nIf the haemogram is abnormal, a bone marrow biopsy is realized. The patient who presents a myelodysplastic syndrome is excluded."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Rate of platelet \\< 100 G/l for less than 12 months ,\n* age = ou \\> 60 years,\n* haemoglobin \\> ou = 12 g / dl at the woman, \\> ou = 13 g/dl at the man,\n* polymorphonuclear neutrophil \\> ou = 1.7 G/l,\n* monocytes \\< ou= 1 G/l,\n* lymphocytes \\< ou = à 4 G/l,\n* VGM \\< 100 fL, blood film normal,\n* informed consent,\n* expectation of life \\> 6 months\n\nExclusion Criteria:\n\n* hepatomegaly,\n* splenomegaly,\n* hepatic abnormality,\n* blood coagulation abnormality,\n* antecedent of auto-immune disease,\n* drug thrombopenia,\n* HIV, VHB or VHC positive,\n* antecedent of malicious tumor in the 5 years before inclusion'}, 'identificationModule': {'nctId': 'NCT01648556', 'acronym': 'PREDI-PTI', 'briefTitle': 'Research of Predictive Factors to Immune Thrombopenic Purpura', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire, Amiens'}, 'officialTitle': 'Research of Predictive Factors to Immune Thrombopenic Purpura in Front of a Thrombopenia in Appearance Isolated in the Elderly', 'orgStudyIdInfo': {'id': 'PI2011_843_0002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'patients with a thrombopenia isolated', 'description': 'Patients of 60 years old and more presenting a thrombopenia isolated with a rate of platelet \\< 100 G/l Blood tests and bone marrow biopsy repeated', 'interventionNames': ['Other: Blood tests and bone marrow biopsy repeated']}], 'interventions': [{'name': 'Blood tests and bone marrow biopsy repeated', 'type': 'OTHER', 'otherNames': ['The test in corticoids by the prednisone per os'], 'description': 'Blood tests are realized for the dosage of the TPO, the dosage of the antiplatelet antibodies, to measure isotopic lifetime of platelet.\n\nThe test in corticoids by the prednisone per os is realized too. The bone marrow biopsy is realized at the inclusion and during follow-ups if the haemogram is abnormal.', 'armGroupLabels': ['patients with a thrombopenia isolated']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80000', 'city': 'Amiens', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jean Pierre MAROLLEAU, MD-PhD', 'role': 'CONTACT'}, {'name': 'Jean-Pierre MAROLLEAU, MD-PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Bruno ROYER, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CHU Amiens', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}], 'centralContacts': [{'name': 'JEAN PIERRE MAROLLEAU', 'role': 'CONTACT', 'email': 'marolleau.jean-pierre@chu-amiens.fr', 'phone': '00 33 33 45 59 14'}], 'overallOfficials': [{'name': 'Jean Pierre MD MAROLLEAU, phD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU AMIENS'}, {'name': 'mathilde HUNAULT BERGER, Ph D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Angers'}, {'name': 'NADINE MAGY BERTRAND, PH D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Universitaire de Besancon'}, {'name': 'Olivier FAIN, PH D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'HOPITAL JEAN VERDIER, BONDY'}, {'name': 'BRIGITTE PAN PETESCH, D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU BREST'}, {'name': 'MICHEL LEPORRIER, PH D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Caen'}, {'name': 'BERTRAND GODEAU, PH D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU CRETEIL'}, {'name': 'PHILIPPE BIERLING, PH D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'EFS IVRY SUR SEINE'}, {'name': 'LOUIS TERRIOU, PH D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHRU LILLE'}, {'name': 'JEAN MARC DURAND, PH D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'LA CONCEPTION MARSEILLE'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire, Amiens', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}