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Haematologic DiseaseINTHEMANCT04298892

Integrated Multiomics and Multilevel Characterization of Haematological Disorders and Malignancies

An observational study of Haematologic Disease and Haematological Malignancy, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 26 sites in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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 Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
clinical data and sample collection
Type of treatment
Pill or oral medicine
How many people
2,000 participants
Where
26 sitesItaly
Study dates
7 Jan 2020to Feb 2025
How long will I take part?
2 Years
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 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.

Who may be able to join

  • 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.

Who cannot join

  • Patients included in clinical trials may be enrolled in this explorative study, except where otherwise clearly indicated in the experimental protocol

Trial locations and contacts

26 sites in 1 country.

Oriana Nanni, Dr contact

+39 0543 739100

oriana.nanni@irst.emr.it

Giorgia Simonetti, Dr contact

+39 0543 739956

giorgia.simonetti@irst.emr.it

26 sites in 1 country

Italy26 sites, 26 recruiting

  • Centro di Riferimento Oncologico - CRO Irccs

    Aviano, 33081

    Valter Gattei, MD

    Recruiting

  • A.O.U. Consorziale policlinico Giovanni XXIII di Bari

    Bari

    Antonio Giovanni Solimando, MD

    Recruiting

  • IRCSS Istituto Tumori

    Bari

    Attilio Guarini, MD

    Recruiting

  • Ospedale A. Perrino

    Brindisi

    Domenico Pastore, MD

    Recruiting

  • Ospedale Santa Croce e Carle

    Cuneo

    Davide Rapezzi, MD

    Recruiting

  • IRCCS Osp. Policlinico San Martino

    Genova

    Roberto Lemoli, MD

    Recruiting

  • Istituto Giannina Gaslini

    Genova

    Carlo Dufour, MD

    Recruiting

  • Irst Irccs

    Meldola, FC, 47014

    Alessandro Lucchesi, MD, alessandro.lucchesi@irst.emr.it

    Recruiting

  • IRCCS Ospedale San Raffaele

    Milan, 20132

    Fabio Ciceri, MD

    Recruiting

  • IEO

    Milan, 20141

    Enrico Derenzini, MD

    Recruiting

  • Istituto Nazionale Tumori Di Napoli Irccs

    Naples, 80131

    Anronio Pinto, MD

    Recruiting

  • AORN " A. Cardarelli"

    Naples

    Ferrara Felicetto, MD

    Recruiting

  • AUO San Luigi Gonzaga

    Orbassano

    Alessandro Morotti, MD

    Recruiting

  • Irccs Iov

    Padova

    Michele Gottardi, MD

    Recruiting

  • AOU "P. Giaccone"

    Palermo

    Mariasanta Napolitano, MD

    Recruiting

  • Fondazione IRCCS Policlinico San Matteo

    Pavia

    Luca Arcaini, MD

    Recruiting

  • P.O. Santo Spirito

    Pescara

    Mario Di Ianni, MD

    Recruiting

  • UO Hematology, Ospedale S. Maria delle Croci

    Ravenna, 48121

    Francesco Lanza, MD

    Recruiting

  • Arcispedale S. Maria Nuova - AUSL IRCCS

    Reggio Emilia

    Annalisa Immovili, MD

    Recruiting

  • UO Hematology Ospedale Infermi

    Rimini, 47923

    Giulia Tolomelli, MD

    Recruiting

  • C.R.O.B. - I.R.C.C.S.

    Rionero in Vulture, Potenza, 85028

    Giuseppe Pietrantuono, MD

    Recruiting

  • IRCCS Fondazione Policlinico Universitario A. Gemelli

    Roma, 00168

    Patrizia Chiusolo, MD

    Recruiting

  • AOU" San Giovanni di Dio e Ruggi d'Aragona"

    Salerno

    Carmine Selleri, MD

    Recruiting

  • AOU Città della Salute e della scienza di Torino

    Torino, TO, 10126

    Recruiting

  • AO Ordine Mauriziano

    Torino, 10128

    Carmen Fava, MD

    Recruiting

  • Ospedale Ca' Foncello Treviso

    Treviso, 31100

    Michele Gottardi, MD

    Recruiting

Other trials in Italy

About this study

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

Read the detailed 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.

Being tested
clinical data and sample collection
Keywords
Hematologic malignancies, omics, integrated, translational
Medical subject headings
Hematologic Diseases, Hematologic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • clinical data and sample collectionOther

    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.

Study groups in NCT04298892
Study groupRoleWhat they receive
hematologic disorder or malignancyNot described
Receives: Other: clinical data and sample collection

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: up to 5 years

Secondary outcomes (7)

  1. Ex vivo Response/resistance

    To define response/resistance to ex vivo drug treatments;

    Measured: up to 5 years

  2. toxicity biomarkers identification

    To identify biomarkers of drug-related toxicity;

    Measured: up to 5 years

  3. Biological and molecular features

    To investigate association between biological and molecular features with patient's clinical features.

    Measured: up to 5 years

  4. Minimal residual disease (MRD)

    To investigate recurrence/minimal residual disease patterns after treatments

    Measured: up to 5 years

  5. 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.

    Measured: up to 5 years

  6. 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.

    Measured: up to 5 years

  7. technological advancement

    To provide a technological advancement potentially applicable to the national health system, when properly validated in appropriate patients' subgroups.

    Measured: up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2020
  2. Study start7 Jan 2020
  3. Primary completionFeb 2025 (estimated)
  4. Study completionFeb 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
2,000 participants (estimated)
Target duration
2 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT04298892
Sponsor's protocol ID
IRSTB100
Acronym
INTHEMA
Status last verified
Sep 2023
First submitted
4 Mar 2020
Last updated
1 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Haematologic Disease and Haematological Malignancy, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 26 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Oriana Nanni, Dr (+39 0543 739100, oriana.nanni@irst.emr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

haematologic diseases characterization (time frame: up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04298892.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2024.

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