Ignite Creation Date:
2025-12-26 @ 10:32 AM
Ignite Modification Date:
2026-02-22 @ 7:04 AM
Study NCT ID:
NCT02967328
Status:
UNKNOWN
Last Update Posted:
2016-11-18
First Post:
2016-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
RP% Measurement by FCM as a Diagnostic Test for ITP
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016553', 'term': 'Purpura, Thrombocytopenic, Idiopathic'}], 'ancestors': [{'id': 'D011696', 'term': 'Purpura, Thrombocytopenic'}, {'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': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'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': 'D007293', 'term': 'Inosine Triphosphate'}], 'ancestors': [{'id': 'D007292', 'term': 'Inosine Nucleotides'}, {'id': 'D011685', 'term': 'Purine Nucleotides'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009711', 'term': 'Nucleotides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012265', 'term': 'Ribonucleotides'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-11-17', 'studyFirstSubmitDate': '2016-11-16', 'studyFirstSubmitQcDate': '2016-11-17', 'lastUpdatePostDateStruct': {'date': '2016-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-11-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total platelet count (RP%)', 'timeFrame': 'The day upon enrollment', 'description': 'We defined an upper limit for healthy control subjects as mean + 3SD in this study.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Reticulated Platelets', 'Immune Thrombocytopenia'], 'conditions': ['Immune Thrombocytopenia']}, 'referencesModule': {'references': [{'pmid': '25618218', 'type': 'RESULT', 'citation': 'Sakuragi M, Hayashi S, Maruyama M, Kabutomori O, Kiyokawa T, Nagamine K, Kato H, Kashiwagi H, Kanakura Y, Tomiyama Y. Clinical significance of IPF% or RP% measurement in distinguishing primary immune thrombocytopenia from aplastic thrombocytopenic disorders. Int J Hematol. 2015 Apr;101(4):369-75. doi: 10.1007/s12185-015-1741-0. Epub 2015 Jan 25.'}, {'pmid': '26831482', 'type': 'RESULT', 'citation': 'Ibrahim H, Nadipalli S, Usmani S, DeLao T, Green L, Kleiman NS. Detection and quantification of circulating immature platelets: agreement between flow cytometric and automated detection. J Thromb Thrombolysis. 2016 Jul;42(1):77-83. doi: 10.1007/s11239-016-1338-3.'}]}, 'descriptionModule': {'briefSummary': 'Immature platelets-also termed reticulated platelets (RP)-are platelets newly released into the circulation, and have been associated with a variety of pathological bleeding events including primary immune thrombocytopenia (ITP). They can be assessed by flow cytometry (FCM) after staining with thiazole orange (TO) at low concentration and expressed as a fraction of the total platelet count (RP%). The diagnosis of primary ITP is based on differential diagnosis and the measurement of RP% can serve as an alternative diagnostic test that are useful in daily practice. Our study aimed at distinguishing primary ITP from other thrombocytopenic disorders, especially aplstic (hypoplastic) or chemotherapy-induced thrombocytopenia by FCM. The sensitivity and specificity of the assay as well as agreement between RP% measurement and monoclonal antibody-specific immobilization of platelet antigen (MAIPA) were analyzed accordingly.', 'detailedDescription': 'The investigators are undertaking a multi-center, prospective blind trial of 500 adults with thrombocytopenic disorders with a platelet count less than 60\\*10\\^9/L from 4 medical centers in China. In brief, 15 μl aliquots of anti-coagulated whole blood were incubated for 70 min with 5 μl of phycoerythrin-conjugated anti-CD42b monoclonal antibody (BD Pharmingen, Tokyo, Japan) and 1 ml of thiazole orange (Retic-COUNT; Becton-Dickinson, San Jose, CA, USA) diluted 10 times by phosphate-buffered saline. RP% was analyzed on a flow cytometer (FACScan, Becton-Dickinson) by measuring 10,000 events in the CD42b-positive fraction.\n\nClinical information of all participants including gender, age, platelet count and definitive diagnosis were recorded by an exclusive investigator. RP% results were revealed at the end of recruitment and after all FCM measurements were completed. The agreement between clinical diagnosis and RP% results were analyzed to identify primary ITP.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '500 adults with thrombocytopenic disorders with a platelet count less than 60000/uL from 4 medical centers in China.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Untreated adult patients of both gender between the ages of 18 and 75 years\n2. Each participant showed a platelet count 60\\*10\\^9/L, with or without bleeding manifestations\n3. Thrombocytopenic disorders including autoimmune-mediated, aplastic (hypoplastic) or chemotherapy-induced thrombocytopenia\n\nExclusion Criteria:\n\n1. Received high-dose steroids or IVIG within 3 weeks prior to the test\n2. Received second-line ITP-specific treatments (eg, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) within 3 months prior to the test\n3. Current HIV infection, hepatitis B virus or hepatitis C virus infections\n4. Severe medical condition (liver and kidney function impairment). Unstable cardiovascular disease or uncontrolled hypertension.\n5. Patients who are deemed unsuitable for the study by the investigator'}, 'identificationModule': {'nctId': 'NCT02967328', 'briefTitle': 'RP% Measurement by FCM as a Diagnostic Test for ITP', 'organization': {'class': 'OTHER', 'fullName': 'Shandong University'}, 'officialTitle': 'A Multi-Center Prospective Blind Study of RP% Measurement by Flow Cytometry in the Diagnosis of Primary Immune Thrombocytopenia', 'orgStudyIdInfo': {'id': 'ITP-Reticulated Platelets'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'RP% Measurement by FCM as a Diagnostic Test for ITP', 'description': 'The investigators are undertaking a multi-center, prospective blind trial of 500 adults with thrombocytopenic disorders with a platelet count less than 60000/uL from 4 medical centers in China. In brief, 15 ul aliquots of anti-coagulated whole blood were incubated for 70 min with 5 ul of phycoerythrin-conjugated anti-CD42b monoclonal antibody (BD Pharmingen, Tokyo, Japan) and 1 ml of thiazole orange (Retic-COUNT; Becton-Dickinson, San Jose, CA, USA) diluted 10 times by phosphate-buffered saline. RP% was analyzed on a flow cytometer (FACScan, Becton-Dickinson) by measuring 10,000 events in the CD42b-positive fraction.', 'interventionNames': ['Other: RP% Measurement by FCM as a Diagnostic Test for ITP']}], 'interventions': [{'name': 'RP% Measurement by FCM as a Diagnostic Test for ITP', 'type': 'OTHER', 'armGroupLabels': ['RP% Measurement by FCM as a Diagnostic Test for ITP']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ming Hou, Dr.', 'role': 'CONTACT', 'email': 'houming@medmail.com.cn', 'phone': '+86-531-82169114', 'phoneExt': '9879'}, {'name': 'Ming Hou, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Qilu Hospital, Shandong University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shandong University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Jinan Central Hospital', 'class': 'OTHER'}, {'name': 'Qianfoshan Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor and Director', 'investigatorFullName': 'Ming Hou', 'investigatorAffiliation': 'Shandong University'}}}}