Ignite Creation Date:
2025-12-24 @ 2:24 PM
Ignite Modification Date:
2025-12-27 @ 5:22 AM
Study NCT ID:
NCT05600959
Status:
NOT_YET_RECRUITING
Last Update Posted:
2022-11-01
First Post:
2022-10-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sensitivity and Specificity of Cytokines in the Diagnosis of Lymphoma-associated HLH
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051359', 'term': 'Lymphohistiocytosis, Hemophagocytic'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D015616', 'term': 'Histiocytosis, Non-Langerhans-Cell'}, {'id': 'D015614', 'term': 'Histiocytosis'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D058408', 'term': 'Th1-Th2 Balance'}], 'ancestors': [{'id': 'D055633', 'term': 'Immune System Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-11-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-27', 'studyFirstSubmitDate': '2022-10-27', 'studyFirstSubmitQcDate': '2022-10-27', 'lastUpdatePostDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The sensitivity and specificity of cytokines to predict lymphoma-associated HLH', 'timeFrame': '1 year', 'description': 'The sensitivity and specificity of cytokines as a means of early diagnosis of lymphoma-associated hemophagocytic lymphohistiocytosis'}], 'secondaryOutcomes': [{'measure': 'Dynamic changes of cytokine levels during treatment', 'timeFrame': '1 years', 'description': 'To monitor the correlation between cytokine levels and disease severity, treatment response and prognosis of lymphoma-associated hemophagocytic lymphohistiocytosis'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hemophagocytic Lymphohistiocytosis', 'Lymphoma', 'Cytokine', 'Diagnosis'], 'conditions': ['Hemophagocytic Lymphohistiocytoses', 'Lymphoma']}, 'descriptionModule': {'briefSummary': 'Lymphoma-associated hemophagocytic lympohistiocytosis is a refractory immune disorder with high mortality. Early identification and diagnosis of lymphoma-associated HLH has become the key to improve the prognosis of lymphoma-associated HLH. Therefore, we conduct a multicenter, prospective, observational clinical study to explore the sensitivity and specificity of cytokines for the early diagnosis of lymphoma-associated HLH.', 'detailedDescription': 'Lymphoma-associated hemophagocytic lympohistiocytosis is a refractory immune disorder with high mortality. Without early intervention, the median survival time is less than 2 months. Early identification and diagnosis of lymphoma-associated HLH has become the key to improve the prognosis of lymphoma-associated HLH. Therefore, it is urgent to find a method for the early diagnosis of lymphoma-associated HLH. We conduct a multicenter, prospective, observational clinical study to explore the sensitivity and specificity of cytokines for the early diagnosis of lymphoma-associated HLH, and its correlation with disease severity, treatment response, and prognosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with lymhoma and patients with lymphoma-associated HLH', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 40-75, gender is not limited.\n* Patients with histopathologically confirmed lymphoma who meet HLH-04 diagnostic criteria, and did not receive systemic chemotherapy before enrollment.\n* Patients with histopathologically confirmed lymphoma who did not receive systemic chemotherapy before enrollment.\n* Informed consent obtained.\n\nExclusion Criteria:\n\n* Patients with severe active infections (viral, bacterial, fungal, or parasitic).\n* Patients with active autoimmune disease or a history of organ transplantation who are receiving immunosuppressive therapy.\n* Patients with other type of malignant tumors within 5 years, except for cured solid tumors.\n* Patients planned to receive immunotherapy.\n* Pregnant and breastfeeding females.\n* History of human immunodeficiency virus (HIV) infection.\n* Acute or chronic active hepatitis B or hepatitis C.\n* Patients assessed as ineligible for the study by the investigator.'}, 'identificationModule': {'nctId': 'NCT05600959', 'briefTitle': 'Sensitivity and Specificity of Cytokines in the Diagnosis of Lymphoma-associated HLH', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Friendship Hospital'}, 'officialTitle': 'The Role of Cytokines in Early Diagnosis, Assessment of Response and Prognosis of Patients With Lymphoma-associated Hemophagocytic Lymphohistiocytosis', 'orgStudyIdInfo': {'id': 'BFH20221009001/BFHHZML20220006'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Lymphoma group', 'description': 'Patients with histopathologically confirmed lymphoma who did not receive systemic chemotherapy before enrollment.', 'interventionNames': ['Diagnostic Test: cytokine']}, {'label': 'Lymphoma-associated HLH group', 'description': 'Patients with histopathologically confirmed lymphoma who meet HLH-04 diagnostic criteria, and did not receive systemic chemotherapy before enrollment.', 'interventionNames': ['Diagnostic Test: cytokine']}], 'interventions': [{'name': 'cytokine', 'type': 'DIAGNOSTIC_TEST', 'description': 'Peripheral blood samples were collected at diagnosis, 2 weeks after the first cycle of chemotherapy and 2 weeks after the second cycle of chemotherapy to monitor cytokine level changes.', 'armGroupLabels': ['Lymphoma group', 'Lymphoma-associated HLH group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100050', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'contacts': [{'name': 'Zhao Wang, MD', 'role': 'CONTACT', 'email': 'wangzhao@ccmu.edu.cn', 'phone': '63138303'}], 'facility': 'Zhao Wang', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Zhao Wang', 'role': 'CONTACT', 'email': 'wangzhao@ccmu.edu.cn', 'phone': '63138303'}], 'overallOfficials': [{'name': 'Zhao Wang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing Friendship Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Friendship Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor and Head of hematology', 'investigatorFullName': 'Zhao Wang', 'investigatorAffiliation': 'Beijing Friendship Hospital'}}}}