Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2025-12-31 @ 1:52 AM
Study NCT ID:
NCT05231135
Status:
RECRUITING
Last Update Posted:
2023-04-06
First Post:
2022-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Registry Study on HIV-related Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016483', 'term': 'Lymphoma, AIDS-Related'}, {'id': 'D008223', 'term': 'Lymphoma'}], 'ancestors': [{'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'targetDuration': '6 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-08-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2029-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-04', 'studyFirstSubmitDate': '2022-01-05', 'studyFirstSubmitQcDate': '2022-01-28', 'lastUpdatePostDateStruct': {'date': '2023-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '2-year overall survival (OS)', 'timeFrame': '2 years', 'description': 'OS measured from the date of diagnosis to last follow-up or to death from any cause.'}, {'measure': '2-year progression-free survival (PFS)', 'timeFrame': '2 years', 'description': 'PFS calculated from the date of diagnosis to the time of progression, relapse, or death.'}], 'secondaryOutcomes': [{'measure': 'Incidence of relapse (IR)', 'timeFrame': '5 years', 'description': 'Based on establised response criteria, e.g. Chesson et al. JCO 2014'}, {'measure': 'Non-relapse mortality (NRM)', 'timeFrame': '5 years', 'description': 'Deaths unrelated to lymphoma'}, {'measure': '5-year overall survival (OS)', 'timeFrame': '5 years', 'description': 'OS measured from the date of diagnosis to last follow-up or to death from any cause.'}, {'measure': '5-year progression-free survival (PFS)', 'timeFrame': '5 years', 'description': 'PFS calculated from the date of diagnosis to the time of progression, relapse, or death.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Malignant lymphoma', 'HIV-related lymphoma', 'HIV-associated Hodgkin lymphoma'], 'conditions': ['AIDS Related Lymphoma', 'HIV Related Lymphoma']}, 'descriptionModule': {'briefSummary': 'Retrospective und prospective registry on HIV-associated lymphoma. Data on characteristics, type and toxicity of treatment and outcome of patients with HIV-lymphoma will be collected.', 'detailedDescription': 'To study characteristics, treatment approaches and outcome of HIV-infected patients with malignant lymphoma in the combination antiretroviral therapy (cART) era. HIV-infected persons diagnosed with non-Hodgkin lymphoma or Hodgkin lymphoma will be included. The choice of treatment is not specified by the registry study. However, the type of antineoplastic treatment should follow national or international recommendations and guidelines. Data will be pseudonymized by the data manager of the treating institution. Central data management is located at Red Cross Hospital Munich, Germany.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Unselected cohort of adults with HIV-lymphoma', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histology or cytology proven non-Hodgkin lymphoma or Hodgkin lymphoma\n* HIV-infection at time of lymphoma diagnosis\n* Lymphoma diagnosis since 01.01.2010\n* Adult patients ≥ 18 years\n* Written informed consent\n\nExclusion Criteria:\n\n* HIV-diagnosis \\> 3 months after the diagnosis of malignant lymphoma\n* Non-Compliance or lack of opportunity for follow-up (for the prospective part of the study)'}, 'identificationModule': {'nctId': 'NCT05231135', 'briefTitle': 'A Registry Study on HIV-related Lymphoma', 'organization': {'class': 'OTHER', 'fullName': 'Rotkreuzklinikum München gGmbH'}, 'officialTitle': 'Characteristics, Treatment and Outcomes of HIV-infected Patients With Malignant Lymphoma: A Registry Study of the European Hematology Association (EHA) Lymphoma Group', 'orgStudyIdInfo': {'id': 'IN03/0121'}}, 'contactsLocationsModule': {'locations': [{'zip': '80634', 'city': 'Munich', 'state': 'Select One Option', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Marcus Hentrich, MD', 'role': 'CONTACT', 'email': 'marcus.hentrich@swmbrk.de', 'phone': '+49 89 1303 4372'}], 'facility': 'Red Cross Hospital Munich', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'zip': '50937', 'city': 'Cologne', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Kai Hübel', 'role': 'CONTACT', 'email': 'kai.huebel@uk-koeln.de', 'phone': '+492214786177'}], 'facility': 'University Hospital Cologne', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'city': 'Amsterdam', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Sanne Tonino, MD, PhD', 'role': 'CONTACT'}, {'role': 'CONTACT', 'email': 's.h.tonino@amsterdamumc.nl'}], 'facility': 'Amsterdam University Medical Centers', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Isabel Regalado Artamendi', 'role': 'CONTACT'}, {'role': 'CONTACT', 'email': 'IRegalado@santpau.cat'}], 'facility': 'Hospital de la Santa Creu i Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Salamanca', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Miguel Alcoceba', 'role': 'CONTACT', 'email': 'alcocebasanchez@saludcastillayleon.es', 'phone': '0034 923 29 11 00', 'phoneExt': '56610'}], 'facility': 'Hospital Universitario de Salamanca', 'geoPoint': {'lat': 40.42972, 'lon': -3.67975}}, {'city': 'Cardiff', 'status': 'NOT_YET_RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Emily Hopkins, MD', 'role': 'CONTACT'}, {'role': 'CONTACT', 'email': 'Emily.Hopkins@wales.nhs.uk'}], 'facility': 'University Hospital of Wales', 'geoPoint': {'lat': 51.48, 'lon': -3.18}}], 'centralContacts': [{'name': 'Marcus Hentrich, MD', 'role': 'CONTACT', 'email': 'marcus.hentrich@swmbrk.de', 'phone': '+49 89 1303 4372'}, {'name': 'Kai Hübel, MD', 'role': 'CONTACT', 'email': 'kai.huebel@uk-koeln.de', 'phone': '+49 221 478 86177'}], 'overallOfficials': [{'name': 'Marcus Hentrich, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Rotkreuzklinikum München'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rotkreuzklinikum München gGmbH', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of the Department of Hematology and Oncology', 'investigatorFullName': 'Prof. Marcus Hentrich', 'investigatorAffiliation': 'Rotkreuzklinikum München gGmbH'}}}}