Feasibility of a Multi-omics Platform for Hematological Malignancies
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,040
- 试验地点
- 1
- 主要终点
- Characterize multi-omics features of different hematological malignancies to identify disease biomarkers
研究概览
简要总结
This is a biological study based on a collaborative effort involving several Italian haematology centres (including the coordinating centre). The study will be conducted retrospectively and prospectively using bone marrow (BM) or peripheral blood (PB) samples, lymph node or tissue biopsies with metastatic involvement, and other biological fluids, such as cerebrospinal fluid and pathological pleural effusion.
详细描述
Concerning the prospective study, the samples will be collected in each participant center during routine diagnostic/relapse investigations. Samples will be sent to our laboratory as fresh or frozen.
Concerning the retrospective part, patients whose frozen samples have been previously received and stored at the THEC of UNIPR for routine diagnostic assessment or other research protocols will be enrolled in the current study.
The hematologic malignancies that will be evaluated in this project include all hematologic entities described in the WHO 2022 classification, such as acute (AML, ALL) or chronic (CLL, CML, HCL) leukemia, myeloproliferative or lymphoproliferative disorders (MF, PV, TE, CMML, NHL, HL), and myelodysplastic or myelodysplastic/myeloproliferative disorders.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient aged > 2 year old
- •Retrospective study:
- •Patients previously diagnosed with hematological malignancies
- •Prospective study:
- •Patients with clinical suspect of hematological malignancies requiring a diagnostic assessment using BM or PB samples, biopsies of lymph nodes or tissues with metastatic involvement, or other biological fluids (such as CSF, pathologic pleural effusion).
- •Patients with clinical suspicion of R/R onco-hematological disorder, requiring a diagnostic assessment using BM aspirate/biopsy or biopsies of tissues with metastatic involvement including lymph nodes, liquor from lumbar puncture, tissue aspirate etc.
- •Patients with blastic transformation from a chronic condition or suspect of R/R hematological disease requiring a diagnostic assessment using PB drawn, BM aspirate/biopsy, lymph nodes biopsies, or biopsies of tissues with metastatic involvement, including CSF from lumbar puncture, tissue aspirate, etc.
排除标准
- •Age <2 year old
- •Patient without a diagnosis of hematological malignancy.
研究组 & 干预措施
Hematological malignancies
Patients with clinical suspect of hematological malignancies or Relapsed and Refractory (R/R) onco-hematological disorders
干预措施: Multi-omics analyses (Other)
Hematological malignancies
Patients with clinical suspect of hematological malignancies or Relapsed and Refractory (R/R) onco-hematological disorders
干预措施: Functional tests (Biological)
结局指标
主要结局
Characterize multi-omics features of different hematological malignancies to identify disease biomarkers
时间窗: At baseline
This will be performed through the application of transcriptomics, phosphoproteomics, metabolomics, genomics, and other omics techniques. Proportion of samples in which ≥1 candidate biomarker is identified through multi-omic assessment (NGS, RNA-seq/Nanostring, single-cell/CITE-seq or phospho-proteomic profiling), categorized by predefined levels of evidence (high/moderate/exploratory according to current guidelines, such as ESCAT (5)).
Evaluate the anti-cancer activity of bioactive compounds and derivatives for functionally pharmacotyping the disease and build a nationally oriented multicenter DRP platform.
时间窗: At baseline
Ex vivo sensitivity to compounds/derivatives: proportion of samples showing ex vivo response to at least one class of compounds of the library according to predefined thresholds on Drug Sensitivity Score (DSS) and/or AUC/IC50. The thresholds are identified based on previous reports, database (e.g. FORALL, Genomic of Drug Sensitivity in Cancer), and internal validation on previous cases assessed in our chemogenomic platform. Additional metrics will include the mean number of active compounds per sample and further application of DSS distribution in the experimental cohort (sDSS, dDSS, zDSS).
次要结局
未报告次要终点
研究者
Giovanni Roti
Professore associato
University of Parma