Integrated Multiomics and Multilevel Characterization of Haematological Disorders and Malignancies

Haematological Malignancy Clinical Trial

— INTHEMA  

Official title:

Integrated Multiomics and Multilevel Characterization of Haematological Disorders and Malignancies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04298892
• Other study ID #: IRSTB100
• Status: Recruiting
• Start date: January 7, 2020
• Est. completion date: February 2025

Study information

• Verified date: September 2023
• Source: Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
• Contact: Oriana Nanni, Dr
• Phone: +39 0543 739100
• Email: oriana.nanni[@]irst.emr.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Haematologic Disease
• Haematological Malignancy
• Hematologic Diseases
• Hematologic Neoplasms
• Neoplasms

Intervention

Other:
• clinical data and sample collection
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.

Locations

Country	Name	City	State
Italy	Irst Irccs	Meldola	FC
Italy	UO Hematology, Ospedale S. Maria delle Croci	Ravenna
Italy	UO Hematology Ospedale Infermi	Rimini
Italy	AOU Città della Salute e della scienza di Torino	Torino	TO
Italy	Ospedale Ca' Foncello Treviso	Treviso

Sponsors (2)

Lead Sponsor	Collaborator
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori	Azienda Unità Sanitaria Locale della Romagna

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Ex vivo Response/resistance	To define response/resistance to ex vivo drug treatments;	up to 5 years
Secondary	toxicity biomarkers identification	To identify biomarkers of drug-related toxicity;	up to 5 years
Secondary	Biological and molecular features	To investigate association between biological and molecular features with patient's clinical features.	up to 5 years
Secondary	Minimal residual disease (MRD)	To investigate recurrence/minimal residual disease patterns after treatments	up to 5 years
Secondary	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
Secondary	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
Secondary	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