Feasibility of a Multi-omics Platform for Hematological Malignancies (FOCUS)

February 25, 2026 updated by: Giovanni Roti, Azienda Ospedaliero-Universitaria di Parma
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

1040

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • PR
      • Parma, PR, Italy, 43126
        • Recruiting
        • University of Parma
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Age <2 year old
  • Patient without a diagnosis of hematological malignancy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Hematological malignancies
Patients with clinical suspect of hematological malignancies or Relapsed and Refractory (R/R) onco-hematological disorders
Biological: Functional tests
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.
Other: Multi-omics analyses
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Characterize multi-omics features of different hematological malignancies to identify disease biomarkers
Time Frame: 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)).
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.
Time Frame: 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).
At baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliero-Universitaria di Parma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 31, 2025

Primary Completion (Estimated)

March 1, 2030

Study Completion (Estimated)

March 1, 2030

Study Registration Dates

First Submitted

February 13, 2026

First Submitted That Met QC Criteria

February 25, 2026

First Posted (Actual)

March 3, 2026

Study Record Updates

Last Update Posted (Actual)

March 3, 2026

Last Update Submitted That Met QC Criteria

February 25, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 662/2024/TESS/UNIPR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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