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Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

Verified date September 2023
Source Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
Contact Oriana Nanni, Dr
Phone +39 0543 739100
Email oriana.nanni@irst.emr.it
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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 clinical data are available may be included in this study, after obtaining informed consent


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 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.


Recruitment information / eligibility

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

Study Design


Intervention

Other:
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.

Locations

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

Sponsors (2)

Lead Sponsor Collaborator
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori Azienda Unità Sanitaria Locale della Romagna

Country where clinical trial is conducted

Italy, 

Outcome

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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