NCT07445438

Feasibility of a Multi-omics Platform for Hematological Malignancies

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,040 (estimated)
• Sponsor: Azienda Ospedaliero-Universitaria di Parma · Academic / Other
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-03-31
• Primary completion: 2030-03-01
• Completion: 2030-03-01
• First posted: 2026-03-03
• Last updated: 2026-03-03

Locations

1 site across 1 country: Italy