Status:
UNKNOWN
Integrated Multiomics and Multilevel Characterization of Haematological Disorders and Malignancies
Lead Sponsor:
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Collaborating Sponsors:
Azienda Unità Sanitaria Locale della Romagna
Conditions:
Haematologic Disease
Haematological Malignancy
Eligibility:
All Genders
18+ years
Brief Summary
Exploratory multicenter, non-interventional, translational, retrospective and prospective study. All patients with a diagnosis of hematologic disorder or malignancy for whom biological samples and cli...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Participant is willing and able to give informed consent for participation in the study
- Male or Female, aged \>18 years
- 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.
- 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);
- 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
- Patients included in clinical trials may be enrolled in this explorative study, except where otherwise clearly indicated in the experimental protocol
Key Trial Info
Start Date :
January 7 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 1 2025
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT04298892
Start Date
January 7 2020
End Date
February 1 2025
Last Update
July 1 2024
Active Locations (26)
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1
Irst Irccs
Meldola, FC, Italy, 47014
2
C.R.O.B. - I.R.C.C.S.
Rionero in Vulture, Potenza, Italy, 85028
3
AOU Città della Salute e della scienza di Torino
Torino, TO, Italy, 10126
4
Centro di Riferimento Oncologico - CRO Irccs
Aviano, Italy, 33081