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| Name | Class |
|---|---|
| Azienda Unità Sanitaria Locale della Romagna | OTHER |
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Exploratory multicenter, non-interventional, translational, retrospective and prospective study. All patients with a diagnosis of hematologic disorder or malignancy for whom biological samples and clinical data are available may be included in this study, after obtaining informed consent
Hematological malignancies account for approximately 9.5% of newly diagnosed cancers every year and their incidence shows an exponential rise after the age of 40. Since life expectancy is dramatically and continuously increasing worldwide, hematological diseases promise to become a substantial burden for the health care systems of the European society. The management of hematological malignancies is further complicated by the high level of disease heterogeneity in terms of pathogenic and molecular mechanisms. Due to the high level of heterogeneity in terms of cytogenetic, genetic, epigenetic, transcriptional, post-transcriptional and metabolic alterations, an accurate molecular classification of hematological diseases is needed to improve clinical outcomes and patients' management. This is an exploratory multicenter, non-interventional, translational, retrospective and prospective study. All patients with a diagnosis of hematologic disorder or malignancy for whom biological samples and clinical data are available may be included in this study, after obtaining informed consent. The primary objective is to improve our knowledge of the pathogenic mechanisms driving malignant disorders and transformation. The secondary objectives aim to improve diagnosis and stratification of onco-hematological patients and study drug response at preclinical level. After signing informed consent to the study, each patient will donate part of the samples (peripheral blood, bone marrow, biopsies) collected as per routine clinical practice for the management of their disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hematologic disorder or malignancy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| clinical data and sample collection | Other | Patients with hematologic malignancies and disorders will be asked to donate part of the samples collected as per clinical practice for the management of their disease for the aims of this study. In addition, patients will be asked to donate one oral swab sample, and urine samples. Collection of these additional samples is a non-invasive procedure with no associated risks for patients. Clinical data (demographics including ethnicity, stage of disease, concise treatment history, cytogenetic reports, and molecular data if available, as routinely performed during diagnosis procedures) will be collected. |
| Measure | Description | Time Frame |
|---|---|---|
| haematologic diseases characterization | To improve our knowledge of the pathogenic mechanisms driving malignant disorders and transformation in different subgroups, defined by molecular, metabolic, proteomic, imaging, preclinical and clinical data integration | up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Ex vivo Response/resistance | To define response/resistance to ex vivo drug treatments; | up to 5 years |
| toxicity biomarkers identification | To identify biomarkers of drug-related toxicity; |
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Inclusion Criteria:
Exclusion Criteria:
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Patients diagnosed with haematological malignancy or disorder (see inclusion criteria) treated in the participating centers will be considered for enrollment. Patients can be enrolled at diagnosis or at relapse. Samples will be collected before treatment, during treatment whenever possible, at follow-up, at remission and at each relapse.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Oriana Nanni, Dr | Contact | +39 0543 739100 | oriana.nanni@irst.emr.it | |
| Giorgia Simonetti, Dr | Contact | +39 0543 739956 | giorgia.simonetti@irst.emr.it |
| Name | Affiliation | Role |
|---|---|---|
| Giovanni Martinelli, Prof | IRST IRCCS | Study Director |
| Alessandro Lucchesi, MD | IRST IRCCS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Irst Irccs | Recruiting | Meldola | FC | 47014 | Italy |
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Fresh peripheral blood, bone marrow, urine, bone biopsy, lymph node biopsy, cerebrospinal, ascites, pericardial and pleural fluid. All samples will be collected according to clinical practice. In addition, a saliva sample will be collected.
|
| up to 5 years |
| Biological and molecular features | To investigate association between biological and molecular features with patient's clinical features. | up to 5 years |
| Minimal residual disease (MRD) | To investigate recurrence/minimal residual disease patterns after treatments | up to 5 years |
| Prognostic and early diagnostic biomarkers | To identify novel biomarkers for early diagnosis (e.g. predictive of transformation from a pre-malignant to an overt malignant phase) and prognosis. | up to 5 years |
| identification of circulating and tissue molecular markers. | To improve the diagnostic work-up of haematological disease, thus enlarging the fraction of patients suitable for curative treatments through the identification of circulating and tissue molecular markers. | up to 5 years |
| technological advancement | To provide a technological advancement potentially applicable to the national health system, when properly validated in appropriate patients' subgroups. | up to 5 years |
| C.R.O.B. - I.R.C.C.S. | Recruiting | Rionero in Vulture | Potenza | 85028 | Italy |
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| AOU Città della Salute e della scienza di Torino | Recruiting | Torino | TO | 10126 | Italy |
| Centro di Riferimento Oncologico - CRO Irccs | Recruiting | Aviano | 33081 | Italy |
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| A.O.U. Consorziale policlinico Giovanni XXIII di Bari | Recruiting | Bari | Italy |
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| IRCSS Istituto Tumori | Recruiting | Bari | Italy |
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| Ospedale A. Perrino | Recruiting | Brindisi | Italy |
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| Ospedale Santa Croce e Carle | Recruiting | Cuneo | Italy |
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| IRCCS Osp. Policlinico San Martino | Recruiting | Genova | Italy |
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| Istituto Giannina Gaslini | Recruiting | Genova | Italy |
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| IRCCS Ospedale San Raffaele | Recruiting | Milan | 20132 | Italy |
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| IEO | Recruiting | Milan | 20141 | Italy |
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| Istituto Nazionale Tumori Di Napoli Irccs | Recruiting | Naples | 80131 | Italy |
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| AORN " A. Cardarelli" | Recruiting | Naples | Italy |
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| AUO San Luigi Gonzaga | Recruiting | Orbassano | Italy |
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| Irccs Iov | Recruiting | Padova | Italy |
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| AOU "P. Giaccone" | Recruiting | Palermo | Italy |
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| Fondazione IRCCS Policlinico San Matteo | Recruiting | Pavia | Italy |
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| P.O. Santo Spirito | Recruiting | Pescara | Italy |
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| UO Hematology, Ospedale S. Maria delle Croci | Recruiting | Ravenna | 48121 | Italy |
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| Arcispedale S. Maria Nuova - AUSL IRCCS | Recruiting | Reggio Emilia | Italy |
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| UO Hematology Ospedale Infermi | Recruiting | Rimini | 47923 | Italy |
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| IRCCS Fondazione Policlinico Universitario A. Gemelli | Recruiting | Roma | 00168 | Italy |
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| AOU" San Giovanni di Dio e Ruggi d'Aragona" | Recruiting | Salerno | Italy |
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| AO Ordine Mauriziano | Recruiting | Torino | 10128 | Italy |
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| Ospedale Ca' Foncello Treviso | Recruiting | Treviso | 31100 | Italy |
|
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D006425 | Hemic and Lymphatic Diseases |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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