Haematological Malignancy Clinical Trial
— INTHEMAOfficial title:
Integrated Multiomics and Multilevel Characterization of Haematological Disorders and Malignancies
NCT number | NCT04298892 |
Other study ID # | IRSTB100 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | January 7, 2020 |
Est. completion date | February 2025 |
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
Status | Recruiting |
Enrollment | 2000 |
Est. completion date | February 2025 |
Est. primary completion date | February 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Participant is willing and able to give informed consent for participation in the study 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: - Patients included in clinical trials may be enrolled in this explorative study, except where otherwise clearly indicated in the experimental protocol |
Country | Name | City | State |
---|---|---|---|
Italy | Irst Irccs | Meldola | FC |
Italy | UO Hematology, Ospedale S. Maria delle Croci | Ravenna | |
Italy | UO Hematology Ospedale Infermi | Rimini | |
Italy | AOU Città della Salute e della scienza di Torino | Torino | TO |
Italy | Ospedale Ca' Foncello Treviso | Treviso |
Lead Sponsor | Collaborator |
---|---|
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori | Azienda Unità Sanitaria Locale della Romagna |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | haematologic diseases characterization | 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 | up to 5 years | |
Secondary | Ex vivo Response/resistance | To define response/resistance to ex vivo drug treatments; | up to 5 years | |
Secondary | toxicity biomarkers identification | To identify biomarkers of drug-related toxicity; | up to 5 years | |
Secondary | Biological and molecular features | To investigate association between biological and molecular features with patient's clinical features. | up to 5 years | |
Secondary | Minimal residual disease (MRD) | To investigate recurrence/minimal residual disease patterns after treatments | up to 5 years | |
Secondary | Prognostic and early diagnostic biomarkers | To identify novel biomarkers for early diagnosis (e.g. predictive of transformation from a pre-malignant to an overt malignant phase) and prognosis. | up to 5 years | |
Secondary | identification of circulating and tissue molecular markers. | 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. | up to 5 years | |
Secondary | technological advancement | To provide a technological advancement potentially applicable to the national health system, when properly validated in appropriate patients' subgroups. | up to 5 years |
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