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临床试验/NCT04298892
NCT04298892招募中不适用

Integrated Multiomics and Multilevel Characterization of Haematological Disorders and Malignancies

Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori26 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2020年1月7日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
2,000
试验地点
26
主要终点
haematologic diseases characterization

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • Patients included in clinical trials may be enrolled in this explorative study, except where otherwise clearly indicated in the experimental protocol

结局指标

主要结局

haematologic diseases characterization

时间窗: up to 5 years

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

次要结局

  • Minimal residual disease (MRD)(up to 5 years)
  • Ex vivo Response/resistance(up to 5 years)
  • toxicity biomarkers identification(up to 5 years)
  • Prognostic and early diagnostic biomarkers(up to 5 years)
  • identification of circulating and tissue molecular markers.(up to 5 years)
  • technological advancement(up to 5 years)
  • Biological and molecular features(up to 5 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (26)

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