Clinical trial NCT04298892: Integrated Multiomics and Multilevel Characterization of Haematological Disorders and Malignancies
Official title: Integrated Multiomics and Multilevel Characterization of Haematological Disorders and Malignancies
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Haematologic Disease
Haematological Malignancy
Keywords: Hematologic malignancies
omics
integrated
translational
Lead sponsor: Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Sponsor class: OTHER
Collaborators: name: Azienda Unità Sanitaria Locale della Romagna
First posted: 2020-03-06
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: haematologic diseases characterization
timeFrame: up to 5 years
Secondary outcomes:
measure: Ex vivo Response/resistance
timeFrame: up to 5 years
measure: toxicity biomarkers identification
timeFrame: up to 5 years
measure: Biological and molecular features
timeFrame: up to 5 years
measure: Minimal residual disease (MRD)
timeFrame: up to 5 years
measure: Prognostic and early diagnostic biomarkers
timeFrame: up to 5 years
measure: identification of circulating and tissue molecular markers.
timeFrame: up to 5 years
measure: technological advancement
timeFrame: up to 5 years
Other outcomes:
Locations:
city: Meldola
country: Italy
facility: Irst Irccs
state: FC
city: Rionero In Vulture
country: Italy
facility: C.R.O.B. - I.R.C.C.S.
state: Potenza
city: Torino
country: Italy
facility: AOU Città della Salute e della scienza di Torino
state: TO
city: Aviano
country: Italy
facility: Centro di Riferimento Oncologico - CRO Irccs
city: Bari
country: Italy
facility: A.O.U. Consorziale policlinico Giovanni XXIII di Bari
city: Bari
country: Italy
facility: IRCSS Istituto Tumori
city: Brindisi
country: Italy
facility: Ospedale A. Perrino
city: Cuneo
country: Italy
facility: Ospedale Santa Croce e Carle
city: Genova
country: Italy
facility: IRCCS Osp. Policlinico San Martino
city: Genova
country: Italy
facility: Istituto Giannina Gaslini
city: Milano
country: Italy
facility: IRCCS Ospedale San Raffaele
city: Milano
country: Italy
facility: IEO
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori Di Napoli Irccs
city: Napoli
country: Italy
facility: AORN " A. Cardarelli"
city: Orbassano
country: Italy
facility: AUO San Luigi Gonzaga
city: Padova
country: Italy
facility: Irccs Iov
city: Palermo
country: Italy
facility: AOU "P. Giaccone"
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo
city: Pescara
country: Italy
facility: P.O. Santo Spirito
city: Ravenna
country: Italy
facility: UO Hematology, Ospedale S. Maria delle Croci
city: Reggio Emilia
country: Italy
facility: Arcispedale S. Maria Nuova - AUSL IRCCS
city: Rimini
country: Italy
facility: UO Hematology Ospedale Infermi
city: Roma
country: Italy
facility: IRCCS Fondazione Policlinico Universitario A. Gemelli
city: Salerno
country: Italy
facility: AOU" San Giovanni di Dio e Ruggi d'Aragona"
city: Torino
country: Italy
facility: AO Ordine Mauriziano
city: Treviso
country: Italy
facility: Ospedale Ca' Foncello Treviso
Study officials:
affiliation: IRST IRCCS
name: Giovanni Martinelli, Prof
role: STUDY_DIRECTOR
affiliation: IRST IRCCS
name: Alessandro Lucchesi, MD
role: PRINCIPAL_INVESTIGATOR
References: