An interventional study of Multi-omics analyses and Functional tests in Myeloma Multiple, Chronic Leukemia and Acute Leukemia, sponsored by Azienda Ospedaliero-Universitaria di Parma. Recruiting at 1 site in Italy. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2026-03-03.
Sponsored by Azienda Ospedaliero-Universitaria di Parma · Not applicable, Interventional, and Basic science
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.
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.
3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.
This study's planned enrollment of 1,040 is above the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →Azienda Ospedaliero-Universitaria di Parma is the lead sponsor of 43 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients with clinical suspect of hematological malignancies or Relapsed and Refractory (R/R) onco-hematological disorders
Other: Multi-omics analyses · Biological: Functional tests
The focus of our scientific approach is based on multi-omics analyses: NGS (Next Generation Sequencing analysis), Bulk Transcriptomics, Single-cell resolution, Single-cell transcriptomics and phosphoproteomics.
Functional analyses will be performed on primary sample from each enrolled patient. Malignant cells are cultered and incubated with a specific library of drugs (300 drugs) at four different concentrations for 72 hours.
Characterize multi-omics features of different hematological malignancies to identify disease biomarkers
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)).
Time frame: At baseline
Evaluate the anti-cancer activity of bioactive compounds and derivatives for functionally pharmacotyping the disease and build a nationally oriented multicenter DRP platform.
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).
Time frame: At baseline
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Azienda Ospedaliero-Universitaria di Parma