Integrated Multiomics and Multilevel Characterization of Haematological Disorders and Malignancies

Last updated: June 28, 2024
Sponsor: Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
Overall Status: Active - Recruiting

Phase

N/A

Condition

Red Blood Cell Disorders

Hematologic Neoplasms

Neoplasms

Treatment

clinical data and sample collection

Clinical Study ID

NCT04298892
IRSTB100
  • Ages > 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Participant is willing and able to give informed consent for participation in thestudy

  2. Male or Female, aged >18 years

  3. Patients with histologically confirmed diagnosis of one of the followinghaematological diseases: monoclonal gammopathy of undetermined significance (MGUS),idiopathic cytopenia of undetermined significance (ICUS), clonal cytopenia ofundetermined significance (CCUS), clonal hematopoiesis of indeterminate potential (CHIP) or hematological malignancies: Peripheral T-cell Lymphomas (PTCL), B- andT-Lymphoblastic Leukemias / Lymphomas (ALL), Burkitt Lymphoma (BL), B and T celllymphoma, Acute Myeloid Leukemia (AML), Myeloproliferative Disease (PolycythemiaVera (PV), Essential Thrombocythemia (ET), Monocytic Leukemia), Chronic LymphocyticLeukemia (CLL), Chronic Myeloid Leukemia (CML), Myelofibrosis, Myelodysplasia (MDS)including Macrocytic Anemia, Sideroblastic Anemia and Non-Neoplastic HematologicDisease, Systemic Mastocytosis, Multiple Myeloma (MM), Plasma Cell Disease.

  4. Available clinical data (demographics including ethnicity, stage of disease, concisetreatment history, cytogenetic reports, and molecular data if available, asroutinely performed during diagnosis procedures);

  5. For the retrospective part of the study: availability of biological samplescollected for routine diagnostics/therapeutic procedures and stored as appropriate,per laboratory standard procedures.

Exclusion

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

Total Participants: 2000
Treatment Group(s): 1
Primary Treatment: clinical data and sample collection
Phase:
Study Start date:
January 07, 2020
Estimated Completion Date:
February 28, 2025

Study 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.

Connect with a study center

  • Irst Irccs

    Meldola, FC 47014
    Italy

    Active - Recruiting

  • C.R.O.B. - I.R.C.C.S.

    Rionero In Vulture, Potenza 85028
    Italy

    Active - Recruiting

  • AOU Città della Salute e della scienza di Torino

    Torino, TO 10126
    Italy

    Active - Recruiting

  • Centro di Riferimento Oncologico - CRO Irccs

    Aviano, 33081
    Italy

    Active - Recruiting

  • A.O.U. Consorziale policlinico Giovanni XXIII di Bari

    Bari,
    Italy

    Active - Recruiting

  • IRCSS Istituto Tumori

    Bari,
    Italy

    Active - Recruiting

  • Ospedale A. Perrino

    Brindisi,
    Italy

    Active - Recruiting

  • Ospedale Santa Croce e Carle

    Cuneo,
    Italy

    Active - Recruiting

  • IRCCS Osp. Policlinico San Martino

    Genova,
    Italy

    Active - Recruiting

  • Istituto Giannina Gaslini

    Genova,
    Italy

    Active - Recruiting

  • IEO

    Milano, 20141
    Italy

    Active - Recruiting

  • IRCCS Ospedale San Raffaele

    Milano, 20132
    Italy

    Active - Recruiting

  • AORN " A. Cardarelli"

    Napoli,
    Italy

    Active - Recruiting

  • Istituto Nazionale Tumori Di Napoli Irccs

    Napoli, 80131
    Italy

    Active - Recruiting

  • AUO San Luigi Gonzaga

    Orbassano,
    Italy

    Active - Recruiting

  • Irccs Iov

    Padova,
    Italy

    Active - Recruiting

  • AOU "P. Giaccone"

    Palermo,
    Italy

    Active - Recruiting

  • Fondazione IRCCS Policlinico San Matteo

    Pavia,
    Italy

    Active - Recruiting

  • P.O. Santo Spirito

    Pescara,
    Italy

    Active - Recruiting

  • UO Hematology, Ospedale S. Maria delle Croci

    Ravenna, 48121
    Italy

    Active - Recruiting

  • Arcispedale S. Maria Nuova - AUSL IRCCS

    Reggio Emilia,
    Italy

    Active - Recruiting

  • UO Hematology Ospedale Infermi

    Rimini, 47923
    Italy

    Active - Recruiting

  • IRCCS Fondazione Policlinico Universitario A. Gemelli

    Roma, 00168
    Italy

    Active - Recruiting

  • AOU" San Giovanni di Dio e Ruggi d'Aragona"

    Salerno,
    Italy

    Active - Recruiting

  • AO Ordine Mauriziano

    Torino, 10128
    Italy

    Active - Recruiting

  • Ospedale Ca' Foncello Treviso

    Treviso, 31100
    Italy

    Active - Recruiting

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