Ignite Creation Date:
2025-12-24 @ 3:41 PM
Ignite Modification Date:
2025-12-28 @ 1:26 PM
Study NCT ID:
NCT04298892
Status:
UNKNOWN
Last Update Posted:
2024-07-01
First Post:
2020-03-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Integrated Multiomics and Multilevel Characterization of Haematological Disorders and Malignancies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D019337', 'term': 'Hematologic Neoplasms'}], 'ancestors': [{'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013048', 'term': 'Specimen Handling'}], '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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Fresh peripheral blood, bone marrow, urine, bone biopsy, lymph node biopsy, cerebrospinal, ascites, pericardial and pleural fluid. All samples will be collected according to clinical practice. In addition, a saliva sample will be collected.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-01-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2025-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-28', 'studyFirstSubmitDate': '2020-03-04', 'studyFirstSubmitQcDate': '2020-03-04', 'lastUpdatePostDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'haematologic diseases characterization', 'timeFrame': 'up to 5 years', 'description': 'To improve our knowledge of the pathogenic mechanisms driving malignant disorders and transformation in different subgroups, defined by molecular, metabolic, proteomic, imaging, preclinical and clinical data integration'}], 'secondaryOutcomes': [{'measure': 'Ex vivo Response/resistance', 'timeFrame': 'up to 5 years', 'description': 'To define response/resistance to ex vivo drug treatments;'}, {'measure': 'toxicity biomarkers identification', 'timeFrame': 'up to 5 years', 'description': 'To identify biomarkers of drug-related toxicity;'}, {'measure': 'Biological and molecular features', 'timeFrame': 'up to 5 years', 'description': "To investigate association between biological and molecular features with patient's clinical features."}, {'measure': 'Minimal residual disease (MRD)', 'timeFrame': 'up to 5 years', 'description': 'To investigate recurrence/minimal residual disease patterns after treatments'}, {'measure': 'Prognostic and early diagnostic biomarkers', 'timeFrame': 'up to 5 years', 'description': 'To identify novel biomarkers for early diagnosis (e.g. predictive of transformation from a pre-malignant to an overt malignant phase) and prognosis.'}, {'measure': 'identification of circulating and tissue molecular markers.', 'timeFrame': 'up to 5 years', 'description': 'To improve the diagnostic work-up of haematological disease, thus enlarging the fraction of patients suitable for curative treatments through the identification of circulating and tissue molecular markers.'}, {'measure': 'technological advancement', 'timeFrame': 'up to 5 years', 'description': "To provide a technological advancement potentially applicable to the national health system, when properly validated in appropriate patients' subgroups."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hematologic malignancies', 'omics', 'integrated', 'translational'], 'conditions': ['Haematologic Disease', 'Haematological Malignancy']}, 'descriptionModule': {'briefSummary': 'Exploratory multicenter, non-interventional, translational, retrospective and prospective study. All patients with a diagnosis of hematologic disorder or malignancy for whom biological samples and clinical data are available may be included in this study, after obtaining informed consent', 'detailedDescription': "Hematological malignancies account for approximately 9.5% of newly diagnosed cancers every year and their incidence shows an exponential rise after the age of 40. Since life expectancy is dramatically and continuously increasing worldwide, hematological diseases promise to become a substantial burden for the health care systems of the European society. The management of hematological malignancies is further complicated by the high level of disease heterogeneity in terms of pathogenic and molecular mechanisms. Due to the high level of heterogeneity in terms of cytogenetic, genetic, epigenetic, transcriptional, post-transcriptional and metabolic alterations, an accurate molecular classification of hematological diseases is needed to improve clinical outcomes and patients' management. This is an exploratory multicenter, non-interventional, translational, retrospective and prospective study. All patients with a diagnosis of hematologic disorder or malignancy for whom biological samples and clinical data are available may be included in this study, after obtaining informed consent. The primary objective is to improve our knowledge of the pathogenic mechanisms driving malignant disorders and transformation. The secondary objectives aim to improve diagnosis and stratification of onco-hematological patients and study drug response at preclinical level. After signing informed consent to the study, each patient will donate part of the samples (peripheral blood, bone marrow, biopsies) collected as per routine clinical practice for the management of their disease."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with haematological malignancy or disorder (see inclusion criteria) treated in the participating centers will be considered for enrollment. Patients can be enrolled at diagnosis or at relapse. Samples will be collected before treatment, during treatment whenever possible, at follow-up, at remission and at each relapse.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Participant is willing and able to give informed consent for participation in the study\n2. Male or Female, aged \\>18 years\n3. Patients with histologically confirmed diagnosis of one of the following haematological diseases: monoclonal gammopathy of undetermined significance (MGUS), idiopathic cytopenia of undetermined significance (ICUS), clonal cytopenia of undetermined significance (CCUS), clonal hematopoiesis of indeterminate potential (CHIP) or hematological malignancies: Peripheral T-cell Lymphomas (PTCL), B- and T-Lymphoblastic Leukemias / Lymphomas (ALL), Burkitt Lymphoma (BL), B and T cell lymphoma, Acute Myeloid Leukemia (AML), Myeloproliferative Disease (Polycythemia Vera (PV), Essential Thrombocythemia (ET), Monocytic Leukemia), Chronic Lymphocytic Leukemia (CLL), Chronic Myeloid Leukemia (CML), Myelofibrosis, Myelodysplasia (MDS) including Macrocytic Anemia, Sideroblastic Anemia and Non-Neoplastic Hematologic Disease, Systemic Mastocytosis, Multiple Myeloma (MM), Plasma Cell Disease.\n4. Available clinical data (demographics including ethnicity, stage of disease, concise treatment history, cytogenetic reports, and molecular data if available, as routinely performed during diagnosis procedures);\n5. For the retrospective part of the study: availability of biological samples collected for routine diagnostics/therapeutic procedures and stored as appropriate, per laboratory standard procedures.\n\nExclusion Criteria:\n\n* Patients included in clinical trials may be enrolled in this explorative study, except where otherwise clearly indicated in the experimental protocol'}, 'identificationModule': {'nctId': 'NCT04298892', 'acronym': 'INTHEMA', 'briefTitle': 'Integrated Multiomics and Multilevel Characterization of Haematological Disorders and Malignancies', 'organization': {'class': 'OTHER', 'fullName': 'Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS'}, 'officialTitle': 'Integrated Multiomics and Multilevel Characterization of Haematological Disorders and Malignancies', 'orgStudyIdInfo': {'id': 'IRSTB100'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'hematologic disorder or malignancy', 'interventionNames': ['Other: clinical data and sample collection']}], 'interventions': [{'name': 'clinical data and sample collection', 'type': 'OTHER', 'description': 'Patients with hematologic malignancies and disorders will be asked to donate part of the samples collected as per clinical practice for the management of their disease for the aims of this study. In addition, patients will be asked to donate one oral swab sample, and urine samples. Collection of these additional samples is a non-invasive procedure with no associated risks for patients. Clinical data (demographics including ethnicity, stage of disease, concise treatment history, cytogenetic reports, and molecular data if available, as routinely performed during diagnosis procedures) will be collected.', 'armGroupLabels': ['hematologic disorder or malignancy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '47014', 'city': 'Meldola', 'state': 'FC', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Alessandro Lucchesi, MD', 'role': 'CONTACT', 'email': 'alessandro.lucchesi@irst.emr.it'}], 'facility': 'Irst Irccs', 'geoPoint': {'lat': 44.12775, 'lon': 12.0626}}, {'zip': '85028', 'city': 'Rionero in Vulture', 'state': 'Potenza', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giuseppe Pietrantuono, MD', 'role': 'CONTACT'}], 'facility': 'C.R.O.B. - I.R.C.C.S.', 'geoPoint': {'lat': 40.92328, 'lon': 15.6711}}, {'zip': '10126', 'city': 'Torino', 'state': 'TO', 'status': 'RECRUITING', 'country': 'Italy', 'facility': 'AOU Città della Salute e della scienza di Torino', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}, {'zip': '33081', 'city': 'Aviano', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Valter Gattei, MD', 'role': 'CONTACT'}], 'facility': 'Centro di Riferimento Oncologico - CRO Irccs', 'geoPoint': {'lat': 46.07056, 'lon': 12.59472}}, {'city': 'Bari', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Antonio Giovanni Solimando, MD', 'role': 'CONTACT'}], 'facility': 'A.O.U. Consorziale policlinico Giovanni XXIII di Bari', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}, {'city': 'Bari', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Attilio Guarini, MD', 'role': 'CONTACT'}], 'facility': 'IRCSS Istituto Tumori', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}, {'city': 'Brindisi', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Domenico Pastore, MD', 'role': 'CONTACT'}], 'facility': 'Ospedale A. Perrino', 'geoPoint': {'lat': 40.63215, 'lon': 17.93607}}, {'city': 'Cuneo', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Davide Rapezzi, MD', 'role': 'CONTACT'}], 'facility': 'Ospedale Santa Croce e Carle', 'geoPoint': {'lat': 44.39071, 'lon': 7.54828}}, {'city': 'Genova', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Roberto Lemoli, MD', 'role': 'CONTACT'}], 'facility': 'IRCCS Osp. Policlinico San Martino', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}, {'city': 'Genova', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Carlo Dufour, MD', 'role': 'CONTACT'}], 'facility': 'Istituto Giannina Gaslini', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}, {'zip': '20132', 'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Fabio Ciceri, MD', 'role': 'CONTACT'}], 'facility': 'IRCCS Ospedale San Raffaele', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '20141', 'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Enrico Derenzini, MD', 'role': 'CONTACT'}], 'facility': 'IEO', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '80131', 'city': 'Napoli', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Anronio Pinto, MD', 'role': 'CONTACT'}], 'facility': 'Istituto Nazionale Tumori Di Napoli Irccs', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'city': 'Napoli', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Ferrara Felicetto, MD', 'role': 'CONTACT'}], 'facility': 'AORN " A. Cardarelli"', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'city': 'Orbassano', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Alessandro Morotti, MD', 'role': 'CONTACT'}], 'facility': 'AUO San Luigi Gonzaga', 'geoPoint': {'lat': 45.00547, 'lon': 7.53813}}, {'city': 'Padua', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Michele Gottardi, MD', 'role': 'CONTACT'}], 'facility': 'Irccs Iov', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}, {'city': 'Palermo', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Mariasanta Napolitano, MD', 'role': 'CONTACT'}], 'facility': 'AOU "P. Giaccone"', 'geoPoint': {'lat': 38.1166, 'lon': 13.3636}}, {'city': 'Pavia', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Luca Arcaini, MD', 'role': 'CONTACT'}], 'facility': 'Fondazione IRCCS Policlinico San Matteo', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}, {'city': 'Pescara', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Mario Di Ianni, MD', 'role': 'CONTACT'}], 'facility': 'P.O. Santo Spirito', 'geoPoint': {'lat': 42.4584, 'lon': 14.20283}}, {'zip': '48121', 'city': 'Ravenna', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Francesco Lanza, MD', 'role': 'CONTACT'}], 'facility': 'UO Hematology, Ospedale S. Maria delle Croci', 'geoPoint': {'lat': 44.41344, 'lon': 12.20121}}, {'city': 'Reggio Emilia', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Annalisa Immovili, MD', 'role': 'CONTACT'}], 'facility': 'Arcispedale S. Maria Nuova - AUSL IRCCS', 'geoPoint': {'lat': 44.69825, 'lon': 10.63125}}, {'zip': '47923', 'city': 'Rimini', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giulia Tolomelli, MD', 'role': 'CONTACT'}], 'facility': 'UO Hematology Ospedale Infermi', 'geoPoint': {'lat': 44.05755, 'lon': 12.56528}}, {'zip': '00168', 'city': 'Roma', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Patrizia Chiusolo, MD', 'role': 'CONTACT'}], 'facility': 'IRCCS Fondazione Policlinico Universitario A. Gemelli', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Salerno', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Carmine Selleri, MD', 'role': 'CONTACT'}], 'facility': 'AOU" San Giovanni di Dio e Ruggi d\'Aragona"', 'geoPoint': {'lat': 40.67545, 'lon': 14.79328}}, {'zip': '10128', 'city': 'Torino', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Carmen Fava, MD', 'role': 'CONTACT'}], 'facility': 'AO Ordine Mauriziano', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}, {'zip': '31100', 'city': 'Treviso', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Michele Gottardi, MD', 'role': 'CONTACT'}], 'facility': "Ospedale Ca' Foncello Treviso", 'geoPoint': {'lat': 45.66673, 'lon': 12.2416}}], 'centralContacts': [{'name': 'Oriana Nanni, Dr', 'role': 'CONTACT', 'email': 'oriana.nanni@irst.emr.it', 'phone': '+39 0543 739100'}, {'name': 'Giorgia Simonetti, Dr', 'role': 'CONTACT', 'email': 'giorgia.simonetti@irst.emr.it', 'phone': '+39 0543 739956'}], 'overallOfficials': [{'name': 'Giovanni Martinelli, Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'IRST IRCCS'}, {'name': 'Alessandro Lucchesi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IRST IRCCS'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS', 'class': 'OTHER'}, 'collaborators': [{'name': 'Azienda Unità Sanitaria Locale della Romagna', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}