Clinical trial · Interventional
Feasibility of a Multi-omics Platform for Hematological Malignancies
NCT07445438CI-TRIAL-00104421FOCUSrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Leukemia | Acute Leukemia | ONTOLOGY_EXACT | 0.90 |
| Chronic Leukemia | Chronic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Lymphoproliferative Disorders | — | UNRESOLVED | — |
| Myelodysplastic Disorders | — | UNRESOLVED | — |
| Myeloma Multiple | Multiple Myeloma | ALIAS | 0.90 |
| Myeloproliferative Disorders | Myeloproliferative Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Functional tests | Biological | — | UNRESOLVED |
| Multi-omics analyses | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Hematological malignancies
- description
- Patients with clinical suspect of hematological malignancies or Relapsed and Refractory (R/R) onco-hematological disorders
- interventionNames
- Other: Multi-omics analyses
- Biological: Functional tests
Primary outcomes (2)
- measure
- Characterize multi-omics features of different hematological malignancies to identify disease biomarkers
- timeFrame
- At baseline
- description
- 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)).
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.