Multi-omics testing for blood and bone marrow cancers
Feasibility of a Multi-omics Platform for Hematological Malignancies
NA · Azienda Ospedaliero-Universitaria di Parma · NCT07445438
This project will test a multi-omics lab approach on bone marrow, blood, biopsy and other fluid samples from people with suspected or known hematologic cancers to see if it can better characterize their disease.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 1040 (estimated) |
| Ages | 2 Years and up |
| Sex | All |
| Sponsor | Azienda Ospedaliero-Universitaria di Parma (other) |
| Locations | 1 site (Parma, PR) |
| Trial ID | NCT07445438 on ClinicalTrials.gov |
What this trial studies
This is a multicenter Italian effort combining retrospective and prospective collection of bone marrow, peripheral blood, lymph node or tissue biopsies, cerebrospinal fluid and other pathological fluids. Samples are collected during routine diagnostic or relapse work-ups at participating centers and sent fresh or frozen to a central laboratory at the University of Parma for analysis. The laboratory will perform integrated multi-omics assays and functional tests to profile genetic, molecular, and cellular features across the full range of WHO 2022 hematologic entities. The goal is to test the feasibility of applying this platform across different sample types and clinical settings.
Who should consider this trial
Good fit: Ideal candidates are people older than 2 years with a suspected or confirmed hematologic malignancy (including newly diagnosed, relapsed/refractory, or blastic transformation) who can provide relevant diagnostic samples such as bone marrow, peripheral blood, biopsies, CSF, or other pathological fluids.
Not a fit: Patients younger than 2 years, those without available or adequate sample types, or individuals without a hematologic malignancy diagnosis are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could give more detailed molecular and functional information to help refine diagnoses and guide personalized treatment choices.
How similar studies have performed: Multi-omics approaches have shown promise in research settings for identifying actionable mutations and disease subtypes, but multicenter feasibility and routine clinical integration are still being established.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Parma, PR
- University of Parma — Parma, PR, Italy (RECRUITING)
Study contacts
- Study coordinator: Giovanni Roti, Associate Professor
- Email: giovanni.roti@unipr.it
- Phone: +39 0521 702200
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Myeloma Multiple, Chronic Leukemia, Acute Leukemia, Myeloproliferative Disorders, Lymphoproliferative Disorders, Myelodysplastic Disorders