Ignite Creation Date:
2025-12-24 @ 2:43 PM
Ignite Modification Date:
2025-12-26 @ 9:19 PM
Study NCT ID:
NCT06712459
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-13
First Post:
2024-11-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Integrated Molecular and Clinical Profiling of Transformed Splenic Marginal Zone Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Diagnostic tumor material collected at the time of histological transformation (mandatory), from spleen, lymph node, extra-nodal site, peripheral blood or bone marrow. If available, also SMZL diagnostic tumor material (from spleen, peripheral blood and/or bone marrow) collected at the time diagnosis will be collected (not mandatory).'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2029-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-07', 'studyFirstSubmitDate': '2024-11-26', 'studyFirstSubmitQcDate': '2024-11-26', 'lastUpdatePostDateStruct': {'date': '2025-05-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of mutations, copy number abnormalities and structural variants at SMZL diagnosis and at HT', 'timeFrame': '30 months: from the end of samples collection to the end of study analysis'}, {'measure': 'Quantification and qualification of lesions acquired at the time of HT.', 'timeFrame': '30 months: from the end of samples collection to the end of study analysis'}, {'measure': 'Prevalence of clonal relationship between SMZL and HT', 'timeFrame': '30 months: from the end of samples collection to the end of study analysis'}], 'secondaryOutcomes': [{'measure': 'Prevalence of HT molecular subtypes defined by genetic lesions', 'timeFrame': '30 months: from the end of samples collection to the end of study analysis'}, {'measure': 'Prevalence of Histological Transformation (HT) molecular subtypes defined by gene expression', 'timeFrame': '30 months: from the end of samples collection to the end of study analysis'}, {'measure': 'Prevalence of HT molecular subtypes defined by genetic methylation profile', 'timeFrame': '30 months: from the end of samples collection to the end of study analysis'}, {'measure': 'Prevalence of molecular features in relation with clinical, laboratory and radiological/Positron Emission Tomography (PET) features at SMZL diagnosis and at HT', 'timeFrame': '30 months: from the end of samples collection to the end of study analysis'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Transformed Splenic Marginal Zone Lymphoma']}, 'descriptionModule': {'briefSummary': 'Histological transformation in Splenic Marginal Zone Lymphoma (t-SMZL) represents an unmet clinical and biological need, invariably associated with poor prognosis and reduced overall survival. At the present time, there are no recommended treatments intended specifically to t-SMZL and little is known about t-SMZL genetic complexity. The aim of this study is to provide information that will help clinicians to better understand the complexity of the disease. The information gained from this study will also lead to more specific and effective treatment for patients with t-SMZL.', 'detailedDescription': "Already existing and coded tumor biological material and health-related patient data will be retrospectively collected from institutional biobanks and patients' charts or electronic medical records upon receipt of ethical approval. Each patient enrolled in the study will be assigned a unique identification numerical code upon registration in the study. The unique identification code will be used to record health-related data and to label biological samples. Health-related data will be collected by electronic case report form (e-CRF) system. Data quality will be insured by query generation.\n\nAnnotated baseline features will include: date of diagnosis, date and tissue type of histological sample collected at diagnosis (spleen and/or bone marrow), age, gender, Eastern Cooperative Oncology Group - Performing Status (ECOG-PS), Ann Arbor stage, Lactate Dehydrogenase (LDH), number and location of extranodal sites, bone marrow involvement and percentage, peripheral blood involvement, bulky disease (\\>7 cm), number of nodal sites, B symptoms, hemoglobin, platelets, lymphocytes, beta-2-microglobulin, albumin, Hepatitis C Virus (HCV) infection, serum paraprotein and type.\n\nAnnotated follow-up features will include: the date of progression to a disease requiring treatment, type of first line treatment, date of start of the first line treatment, date of progression after first line treatment, date of the second line treatment, type of second line treatment.\n\nAnnotated transformation features will include: date of transformation, date and type of histological sample collected at transformation (spleen and/or bone marrow and/or lymph node and/or other site), histological transformation type and relative molecular data (if available), ECOG-PS, Ann Arbor stage, LDH, number and location of extranodal sites, bone marrow involvement and percentage, peripheral blood involvement, bulky disease (\\>7 cm), number of nodal sites, B symptoms, hemoglobin, platelets, lymphocytes, beta-2-microglobulin, albumin, serum paraprotein, and type.\n\nSurvival features will include the date of death, cause of death, date of last follow-up.\n\nMutation analysis, immunoglobulin gene rearrangement analysis, copy number aberration analysis, structural variant analysis, and DNA methylation profile will be performed by Next Generation Sequencing (NGS) of genomic DNA extracted from the biological sample available for the analysis. Gene expression will be assessed by NGS of RNA extracted from from the biological sample available for the analysis."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients with transformed SMZL', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adults aged 18 years or older, regardless of the gender;\n2. Diagnosis of HT of SMZL (both at baseline, co-occurring with diagnosis of SMZL, or during the natural history of the disease);\n3. Availability of diagnostic tumor material (either frozen or FFPE) from spleen, lymph node, extra nodal site, peripheral blood or bone marrow collected at the time of histological transformation. Tumor material (either frozen or FFPE), from spleen, peripheral blood or bone marrow, collected at the time of SMZL diagnosis will be also collected, if available;\n4. Availability of the baseline and follow-up annotations.\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT06712459', 'briefTitle': 'Integrated Molecular and Clinical Profiling of Transformed Splenic Marginal Zone Lymphoma', 'organization': {'class': 'OTHER', 'fullName': 'International Extranodal Lymphoma Study Group (IELSG)'}, 'officialTitle': 'Integrated Molecular and Clinical Profiling of Transformed Splenic Marginal Zone Lymphoma', 'orgStudyIdInfo': {'id': 'IELSG54'}}, 'contactsLocationsModule': {'locations': [{'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'contacts': [{'name': 'Govind Bhagat, MD', 'role': 'CONTACT', 'email': 'gb96@cumc.columbia.edu'}, {'name': 'Govind Bhagat, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Columbia University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'contacts': [{'name': 'Thomas Tousseyn, MD', 'role': 'CONTACT', 'email': 'thomas.tousseyn@kuleuven.be'}, {'name': 'Thomas Tousseyn, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Universitz Hospitals Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '75475', 'city': 'Paris', 'country': 'France', 'contacts': [{'name': 'Catherine Thieblemont, MD', 'role': 'CONTACT', 'email': 'catherine.thieblemont@aphp.fr'}, {'name': 'Catherine Thieblemont, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpital Saint Louis', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Heidelberg', 'country': 'Germany', 'contacts': [{'name': 'Sascha Dietrich, MD', 'role': 'CONTACT', 'email': 'Sascha.Dietrich@med.uni-heidelberg.de'}, {'name': 'Sascha Dietrich, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Heidelberg', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '27100', 'city': 'Pavia', 'country': 'Italy', 'contacts': [{'name': 'Luca Arcaini, MD', 'role': 'CONTACT', 'email': 'luca.arcaini@unipv.it'}, {'name': 'Luca Arcaini, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Fondazione IRCCS Policlinico San Matteo', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}, {'zip': '6500', 'city': 'Bellinzona', 'country': 'Switzerland', 'contacts': [{'name': 'Maria Cristina Pirosa, MD', 'role': 'CONTACT', 'email': 'maria.pirosa@eoc.ch'}, {'name': 'Maria Cristina Pirosa, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Oncology Institute of Southern Switzerland', 'geoPoint': {'lat': 46.19278, 'lon': 9.01703}}, {'zip': 'BH7 7DW', 'city': 'Bournemouth', 'country': 'United Kingdom', 'contacts': [{'name': 'Renata Walewska, MD', 'role': 'CONTACT', 'email': 'Renata.Walewska@uhd.nhs.uk'}, {'name': 'Renata Walewska, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospitals Dorset', 'geoPoint': {'lat': 50.72048, 'lon': -1.8795}}], 'centralContacts': [{'name': 'IELSG Study Coordination Office', 'role': 'CONTACT', 'email': 'ielsg@ior.usi.ch', 'phone': '+41 58 666 7321'}, {'name': 'Davide Rossi, MD', 'role': 'CONTACT', 'email': 'davide.rossi@eoc.ch', 'phone': '+41 91 811 8540'}], 'overallOfficials': [{'name': 'Luca Arcaini, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Fondazione IRCCS Policlinico San Matteo'}, {'name': 'Davide Rossi, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Oncology Institute of Southern Switzerland (IOSI) and Institute of Oncology Research (IOR)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'International Extranodal Lymphoma Study Group (IELSG)', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}