An interventional study of Genetic, molecular and/or omics analyses in Chronic Leukemia, Acute Leukemia and Myeloproliferative Disorders, sponsored by Azienda Ospedaliero-Universitaria di Parma. Recruiting at 1 site in Italy. Open to participants aged 1 Year and older. Per ClinicalTrials.gov, last updated 2026-03-03.
Sponsored by Azienda Ospedaliero-Universitaria di Parma · Not applicable, Interventional, and Basic science
The study will be conducted retrospectively and prospectively, using bone marrow (BM) or peripheral blood (PB) samples or biopsies of lymph nodes or tissues with metastatic involvement taken from previously stored samples here at the University Hospital of Parma or taken from patients that need to underwent diagnostic evaluation for a suspect or a defined diagnosis of hematological malignancies collected at the University Hospital of Parma.
The hematological malignancies are referred to all the different hematological entities according to WHO 2016 Classification such as acute (AML, ALL) or chronic leukemia (CLL, CML, HCL), myeloproliferative or lymphoproliferative disorders (MF, PV, TE, CMML, NHL, HL) and myelodysplastic or myelodysplastic/myeloproliferative disorders.
626 studies on the registry are indexed under Myeloproliferative Disorders; 109 are open to participants now.
This study's planned enrollment of 250 is above the median of 45 across 439 interventional studies indexed under Myeloproliferative Disorders.
Browse Myeloproliferative Disorders 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 hematological malignancies either treatment free or relapsed/ refractory
Other: Genetic, molecular and/or omics analyses
The focus of our scientific approach is based on genetic, molecular and/or omics analyses performed with new technologies (Nanostring, NGS, single cell technologies, radiomics)
To evaluate the anti-cancer activity of bio-active compounds and derivatives present in FDA/EMA approved or investigator provided libraries, investigational molecules
The study will be performed in malignant cells of a cohort of 250 patients with onco-hematological disorders obtained from a bone marrow aspirate/biopsy or biopsies of tissues with metastatic involvement including lymph nodes, liquor from rachicentesis, tissue aspirate etc. separated by a tissue-specific protocol: densitometry protocol for peripheral or bone marrow blood, tissue fractionation for tissue biopsies, precipitation for liquor. Cells will be than cultured in the presence or absence of small molecules derived from chemical library FDA/EMA approved, investigational molecules (monoclonal antibodies, antibody-drug conjugate, other experimental compounds). We will use miniaturized assays such cell culture in 384 multiwell plates to maximize the use of primary cells and to test simultaneously multiple concentrations of multiple drugs. We will perform several assays to assess cellular response to drug's perturbation such as: proliferation, cell cycle and apoptosis analysis
Time frame: At baseline
To characterize molecular biomarkers for the identification of novel target therapies
Thanks to genetic and molecular and/or omics analyses performed with new technologies (Nanostring, NGS, single cell technologies, radiomics), we propose to study novel molecular target that may be sensitive to the tested compounds in order to identify new target therapies.
Time frame: At baseline
Correlate anti-cancer response with diagnostic (WHO classification) and molecular or novel omics features including cytogenetics, genomics, next generation or single cell technologies, radiomics.
The completion of experiments described in aim 1 will give us the opportunity, for example, to extrapolate the IC50 (half maximal inhibitory concentration: a measure of the effectiveness of a substance in inhibiting a specific biological or biochemical function) dose for a small molecule of interest and correlate this value with clinical, cytogenetic, genomic and molecular features of that particular case. These data will be further compared with larger repository publicly available in the literature.
Time frame: At baseline
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Azienda Ospedaliero-Universitaria di Parma