Clinical trial · Interventional
Chemogenomic Profiling in Hematological Malignancies (HEM-Profiling 2021)
NCT07445984CI-TRIAL-00104511recruitingN/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)
The study will be conducted retrospectively and prospectively, using bone marrow (BM) or peripheral blood (PB) samples or biopsies of lymph nodes or tissues with metastatic involvement taken from previously stored samples here at the University Hospital of Parma or taken from patients that need to underwent diagnostic evaluation for a suspect or a defined diagnosis of hematological malignancies collected at the University Hospital of Parma.
Conditions
Conditions (5)
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 | — |
| Myeloproliferative Disorders | Myeloproliferative Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Genetic, molecular and/or omics analyses | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Hematological malignancies
- description
- Patients with hematological malignancies either treatment free or relapsed/ refractory
- interventionNames
- Other: Genetic, molecular and/or omics analyses
Primary outcomes (3)
- measure
- To evaluate the anti-cancer activity of bio-active compounds and derivatives present in FDA/EMA approved or investigator provided libraries, investigational molecules
- timeFrame
- At baseline
- description
- The study will be performed in malignant cells of a cohort of 250 patients with onco-hematological disorders obtained from a bone marrow aspirate/biopsy or biopsies of tissues with metastatic involvement including lymph nodes, liquor from rachicentesis, tissue aspirate etc. separated by a tissue-specific protocol: densitometry protocol for peripheral or bone marrow blood, tissue fractionation for tissue biopsies, precipitation for liquor. Cells will be than cultured in the presence or absence of small molecules derived from chemical library FDA/EMA approved, investigational molecules (monoclonal antibodies, antibody-drug conjugate, other experimental compounds). We will use miniaturized assays such cell culture in 384 multiwell plates to maximize the use of primary cells and to test simultaneously multiple concentrations of multiple drugs. We will perform several assays to assess cellular response to drug's perturbation such as: proliferation, cell cycle and apoptosis analysis
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
Show eligibility criteria text
Inclusion Criteria: * Patient aged \>1 year old, referred for evaluation to the University Hospital of Parma; * Retrospective study: previously patients with hematological malignancies; * Prospective study: 1) patients with clinical suspect of hematological malignancies which requires a diagnostic assessment using peripheral blood drawn, bone marrow aspirate/biopsy, lymph nodes biopsies or biopsies of tissues with metastatic involvement including liquor from rachicentesis, tissue aspirate etc. 2) patients with clinical suspect of relapsed/refractory onco-hematological disorder, which requires a diagnostic assessment using bone marrow aspirate/biopsy or biopsies of tissues with metastatic involvement including lymph nodes, liquor from rachicentesis, tissue aspirate etc. 3) patients that progress in blastic transformation from a chronic condition or suspect of relapsed/refractory hematological disease, which requires a diagnostic assessment using peripheral blood drawn, bone marrow aspirate/biopsy, lymph nodes biopsies or biopsies of tissues with metastatic involvement including liquor from rachicentesis, tissue aspirate etc; * Written informed consent. Retrospective study: informed consent will be signed during the first follow-up visit. Exclusion Criteria: * Age \<1 year old * Patients who are unable to provide informed consent prior to any procedure for any reason.
References
Publications (0)
Data not yet available
No reference posted for this study.