Integrated Multiomics and Multilevel Characterization of Haematological Disorders and Malignancies
NCT ID: NCT04298892
Last Updated: 2024-07-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
2000 participants
OBSERVATIONAL
2020-01-07
2025-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
OTHER
Study Groups
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hematologic disorder or malignancy
clinical data and sample collection
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.
Interventions
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clinical data and sample collection
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.
Eligibility Criteria
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Inclusion Criteria
2. Male or Female, aged \>18 years
3. 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.
4. 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);
5. 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.
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Azienda Unità Sanitaria Locale della Romagna
OTHER
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
OTHER
Responsible Party
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Principal Investigators
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Giovanni Martinelli, Prof
Role: STUDY_DIRECTOR
IRST IRCCS
Alessandro Lucchesi, MD
Role: PRINCIPAL_INVESTIGATOR
IRST IRCCS
Locations
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Istituto Giannina Gaslini
Genova, , Italy
IRCCS Ospedale San Raffaele
Milan, , Italy
IEO
Milan, , Italy
Istituto Nazionale Tumori Di Napoli Irccs
Napoli, , Italy
AORN " A. Cardarelli"
Napoli, , Italy
AUO San Luigi Gonzaga
Orbassano, , Italy
Irccs Iov
Padua, , Italy
AOU "P. Giaccone"
Palermo, , Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, , Italy
P.O. Santo Spirito
Pescara, , Italy
UO Hematology, Ospedale S. Maria delle Croci
Ravenna, , Italy
Arcispedale S. Maria Nuova - AUSL IRCCS
Reggio Emilia, , Italy
UO Hematology Ospedale Infermi
Rimini, , Italy
IRCCS Fondazione Policlinico Universitario A. Gemelli
Roma, , Italy
AOU" San Giovanni di Dio e Ruggi d'Aragona"
Salerno, , Italy
AO Ordine Mauriziano
Torino, , Italy
Ospedale Ca' Foncello Treviso
Treviso, , Italy
Irst Irccs
Meldola, FC, Italy
C.R.O.B. - I.R.C.C.S.
Rionero in Vulture, Potenza, Italy
AOU Città della Salute e della scienza di Torino
Torino, TO, Italy
Centro di Riferimento Oncologico - CRO Irccs
Aviano, , Italy
A.O.U. Consorziale policlinico Giovanni XXIII di Bari
Bari, , Italy
IRCSS Istituto Tumori
Bari, , Italy
Ospedale A. Perrino
Brindisi, , Italy
Ospedale Santa Croce e Carle
Cuneo, , Italy
IRCCS Osp. Policlinico San Martino
Genova, , Italy
Countries
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Central Contacts
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Facility Contacts
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Giuseppe Pietrantuono, MD
Role: primary
Valter Gattei, MD
Role: primary
Antonio Giovanni Solimando, MD
Role: primary
Attilio Guarini, MD
Role: primary
Domenico Pastore, MD
Role: primary
Davide Rapezzi, MD
Role: primary
Roberto Lemoli, MD
Role: primary
Carlo Dufour, MD
Role: primary
Fabio Ciceri, MD
Role: primary
Enrico Derenzini, MD
Role: primary
Anronio Pinto, MD
Role: primary
Ferrara Felicetto, MD
Role: primary
Alessandro Morotti, MD
Role: primary
Michele Gottardi, MD
Role: primary
Mariasanta Napolitano, MD
Role: primary
Luca Arcaini, MD
Role: primary
Mario Di Ianni, MD
Role: primary
Francesco Lanza, MD
Role: primary
Annalisa Immovili, MD
Role: primary
Giulia Tolomelli, MD
Role: primary
Patrizia Chiusolo, MD
Role: primary
Carmine Selleri, MD
Role: primary
Carmen Fava, MD
Role: primary
Michele Gottardi, MD
Role: primary
Other Identifiers
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IRSTB100
Identifier Type: -
Identifier Source: org_study_id
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