Characterization of blood disorders and cancers using multiomics
Integrated Multiomics and Multilevel Characterization of Haematological Disorders and Malignancies
This study is trying to better understand blood disorders and cancers by collecting samples from patients to see how their conditions can be classified and treated more effectively.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS Academic / other |
| Locations | 26 sites (Meldola, FC and 25 other locations) |
| Trial ID | NCT04298892 on ClinicalTrials.gov |
What this trial studies
This observational study aims to enhance understanding of hematological disorders and malignancies through an integrated multiomics approach. It will collect biological samples and clinical data from patients diagnosed with various hematological conditions, both retrospectively and prospectively. The study seeks to improve molecular classification, diagnosis, and treatment stratification for these diseases, addressing the high heterogeneity and complexity associated with them. Participants will provide informed consent and donate samples such as blood and bone marrow for analysis.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years with a confirmed diagnosis of specific hematological disorders or malignancies.
Not a fit: Patients without a confirmed hematological disorder or those under 18 years old may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnosis and treatment strategies for patients with hematological malignancies.
How similar studies have performed: Other studies utilizing multiomics approaches in hematological malignancies have shown promise, indicating potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Participant is willing and able to give informed consent for participation in the study 2. Male or Female, aged \>18 years 3. Patients with histologically confirmed diagnosis of one of the following haematological diseases: monoclonal gammopathy of undetermined significance (MGUS), idiopathic cytopenia of undetermined significance (ICUS), clonal cytopenia of undetermined significance (CCUS), clonal hematopoiesis of indeterminate potential (CHIP) or hematological malignancies: Peripheral T-cell Lymphomas (PTCL), B- and T-Lymphoblastic Leukemias / Lymphomas (ALL), Burkitt Lymphoma (BL), B and T cell lymphoma, Acute Myeloid Leukemia (AML), Myeloproliferative Disease (Polycythemia Vera (PV), Essential Thrombocythemia (ET), Monocytic Leukemia), Chronic Lymphocytic Leukemia (CLL), Chronic Myeloid Leukemia (CML), Myelofibrosis, Myelodysplasia (MDS) including Macrocytic Anemia, Sideroblastic Anemia and Non-Neoplastic Hematologic Disease, Systemic Mastocytosis, Multiple Myeloma (MM), Plasma Cell Disease. 4. Available clinical data (demographics including ethnicity, stage of disease, concise treatment history, cytogenetic reports, and molecular data if available, as routinely performed during diagnosis procedures); 5. For the retrospective part of the study: availability of biological samples collected for routine diagnostics/therapeutic procedures and stored as appropriate, per laboratory standard procedures. Exclusion Criteria: * Patients included in clinical trials may be enrolled in this explorative study, except where otherwise clearly indicated in the experimental protocol
Where this trial is running
Meldola, FC and 25 other locations
- Irst Irccs — Meldola, Fc, Italy (Recruiting)
- C.r.o.b. - I.r.c.c.s. — Rionero In Vulture, Potenza, Italy (Recruiting)
- AOU Città della Salute e della scienza di Torino — Torino, To, Italy (Recruiting)
- Centro di Riferimento Oncologico - CRO Irccs — Aviano, Italy (Recruiting)
- A.O.U. Consorziale policlinico Giovanni XXIII di Bari — Bari, Italy (Recruiting)
- IRCSS Istituto Tumori — Bari, Italy (Recruiting)
- Ospedale A. Perrino — Brindisi, Italy (Recruiting)
- Ospedale Santa Croce e Carle — Cuneo, Italy (Recruiting)
- IRCCS Osp. Policlinico San Martino — Genova, Italy (Recruiting)
- Istituto Giannina Gaslini — Genova, Italy (Recruiting)
- IRCCS Ospedale San Raffaele — Milano, Italy (Recruiting)
- Ieo — Milano, Italy (Recruiting)
- Istituto Nazionale Tumori Di Napoli Irccs — Napoli, Italy (Recruiting)
- AORN " A. Cardarelli" — Napoli, Italy (Recruiting)
- AUO San Luigi Gonzaga — Orbassano, Italy (Recruiting)
- Irccs Iov — Padova, Italy (Recruiting)
- AOU "P. Giaccone" — Palermo, Italy (Recruiting)
- Fondazione IRCCS Policlinico San Matteo — Pavia, Italy (Recruiting)
- P.O. Santo Spirito — Pescara, Italy (Recruiting)
- UO Hematology, Ospedale S. Maria delle Croci — Ravenna, Italy (Recruiting)
- Arcispedale S. Maria Nuova - AUSL IRCCS — Reggio Emilia, Italy (Recruiting)
- UO Hematology Ospedale Infermi — Rimini, Italy (Recruiting)
- IRCCS Fondazione Policlinico Universitario A. Gemelli — Roma, Italy (Recruiting)
- AOU" San Giovanni di Dio e Ruggi d'Aragona" — Salerno, Italy (Recruiting)
- AO Ordine Mauriziano — Torino, Italy (Recruiting)
- Ospedale Ca' Foncello Treviso — Treviso, Italy (Recruiting)
Study contacts
- Principal investigator: Alessandro Lucchesi, MD — Irst Irccs
- Study coordinator: Oriana Nanni, Dr
- Email: oriana.nanni@irst.emr.it
- Phone: +39 0543 739100
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.