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Recruiting NCT07445438

Feasibility of a Multi-omics Platform for Hematological Malignancies

No phase Interventional Myeloma Multiple Chronic Leukemia Acute Leukemia Myeloproliferative Disorders

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Multi-omics analyses, Functional tests.
Who it may be relevant to
Registry conditions: Myeloma Multiple, Chronic Leukemia, Acute Leukemia, Myeloproliferative Disorders. Basic parameters: from 2 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

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.

Interventions

  • 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.
  • 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.

Primary outcome measures

  • Characterize multi-omics features of different hematological malignancies to identify disease biomarkers [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. [Time frame: At baseline]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

Italy · 1 center
  • University of Parma — Parma

Identifiers

NCT: NCT07445438 · 662/2024/TESS/UNIPR

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗