Integrated Multiomics and Multilevel Characterization of Haematological Disorders and Malignancies
INTHEMA
1 other identifier
observational
2,000
1 country
26
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2020
Longer than P75 for all trials
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 7, 2020
CompletedFirst Submitted
Initial submission to the registry
March 4, 2020
CompletedFirst Posted
Study publicly available on registry
March 6, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2025
CompletedJuly 1, 2024
September 1, 2023
5.1 years
March 4, 2020
June 28, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
Ex vivo Response/resistance
up to 5 years
toxicity biomarkers identification
up to 5 years
Biological and molecular features
up to 5 years
Minimal residual disease (MRD)
up to 5 years
Prognostic and early diagnostic biomarkers
up to 5 years
- +2 more secondary outcomes
Study Arms (1)
hematologic disorder or malignancy
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- Participant is willing and able to give informed consent for participation in the study
- Male or Female, aged \>18 years
- 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.
- 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);
- 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.
You may not qualify if:
- Patients included in clinical trials may be enrolled in this explorative study, except where otherwise clearly indicated in the experimental protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
Irst Irccs
Meldola, FC, 47014, Italy
C.R.O.B. - I.R.C.C.S.
Rionero in Vulture, Potenza, 85028, Italy
AOU Città della Salute e della scienza di Torino
Torino, TO, 10126, Italy
Centro di Riferimento Oncologico - CRO Irccs
Aviano, 33081, Italy
A.O.U. Consorziale policlinico Giovanni XXIII di Bari
Bari, Italy
IRCSS Istituto Tumori
Bari, Italy
Ospedale A. Perrino
Brindisi, Italy
Ospedale Santa Croce e Carle
Cuneo, Italy
IRCCS Osp. Policlinico San Martino
Genova, Italy
Istituto Giannina Gaslini
Genova, Italy
IRCCS Ospedale San Raffaele
Milan, 20132, Italy
IEO
Milan, 20141, Italy
Istituto Nazionale Tumori Di Napoli Irccs
Napoli, 80131, Italy
AORN " A. Cardarelli"
Napoli, Italy
AUO San Luigi Gonzaga
Orbassano, Italy
Irccs Iov
Padua, Italy
AOU "P. Giaccone"
Palermo, Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, Italy
P.O. Santo Spirito
Pescara, Italy
UO Hematology, Ospedale S. Maria delle Croci
Ravenna, 48121, Italy
Arcispedale S. Maria Nuova - AUSL IRCCS
Reggio Emilia, Italy
UO Hematology Ospedale Infermi
Rimini, 47923, Italy
IRCCS Fondazione Policlinico Universitario A. Gemelli
Roma, 00168, Italy
AOU" San Giovanni di Dio e Ruggi d'Aragona"
Salerno, Italy
AO Ordine Mauriziano
Torino, 10128, Italy
Ospedale Ca' Foncello Treviso
Treviso, 31100, Italy
Biospecimen
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.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Giovanni Martinelli, Prof
IRST IRCCS
- PRINCIPAL INVESTIGATOR
Alessandro Lucchesi, MD
IRST IRCCS
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Target Duration
- 2 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 4, 2020
First Posted
March 6, 2020
Study Start
January 7, 2020
Primary Completion
February 1, 2025
Study Completion
February 1, 2025
Last Updated
July 1, 2024
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share