Feasibility of a Multi-omics Platform for Hematological Malignancies

NCT07445438 | Recruiting

• 1 other identifier: 662/2024/TESS/UNIPR
• Study Type: interventional
• Target: 1,040
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Myeloma Multiple; Chronic Leukemia; Acute Leukemia; Myeloproliferative Disorders; Lymphoproliferative Disorders; Myelodysplastic Disorders

Outcome Measures

Primary Outcomes (2)

• 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)).

  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).

  At baseline

Study Arms (1)

Hematological malignancies

OTHER

Patients with clinical suspect of hematological malignancies or Relapsed and Refractory (R/R) onco-hematological disorders

Other: Multi-omics analyses; Biological: Functional tests

Interventions

Multi-omics analyses OTHER

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.

Hematological malignancies

Functional tests BIOLOGICAL

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.

Hematological malignancies

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria di Parma: lead

Study Sites (1)

University of Parma

Parma, PR, 43126, Italy

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma; Myeloproliferative Disorders; Lymphoproliferative Disorders

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Immunoproliferative Disorders; Immune System Diseases; Bone Marrow Diseases; Lymphatic Diseases

Central Study Contacts

Giovanni Roti, Associate Professor

CONTACT

+39 0521 702200; giovanni.roti@unipr.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professore associato

Study Record Dates

• First Submitted: February 13, 2026
• First Posted: March 3, 2026
• Study Start: March 31, 2025
• Primary Completion (Estimated): March 1, 2030
• Study Completion (Estimated): March 1, 2030
• Last Updated: March 3, 2026

Record last verified: 2026-02

Locations

IT (1)