Integrated Multiomics and Multilevel Characterization of Haematological Disorders and Malignancies (INTHEMA)

June 28, 2024 updated by: Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Italy
      • Aviano, Italy, 33081
        • Recruiting
        • Centro di Riferimento Oncologico - CRO Irccs
        • Contact:
          • Valter Gattei, MD
      • Bari, Italy
        • Recruiting
        • A.O.U. Consorziale policlinico Giovanni XXIII di Bari
        • Contact:
          • Antonio Giovanni Solimando, MD
      • Bari, Italy
        • Recruiting
        • IRCSS Istituto Tumori
        • Contact:
          • Attilio Guarini, MD
      • Brindisi, Italy
        • Recruiting
        • Ospedale A. Perrino
        • Contact:
          • Domenico Pastore, MD
      • Cuneo, Italy
        • Recruiting
        • Ospedale Santa Croce e Carle
        • Contact:
          • Davide Rapezzi, MD
      • Genova, Italy
        • Recruiting
        • Istituto Giannina Gaslini
        • Contact:
          • Carlo Dufour, MD
      • Genova, Italy
        • Recruiting
        • IRCCS Osp. Policlinico San Martino
        • Contact:
          • Roberto Lemoli, MD
      • Milano, Italy, 20132
        • Recruiting
        • IRCCS Ospedale San Raffaele
        • Contact:
          • Fabio Ciceri, MD
      • Milano, Italy, 20141
        • Recruiting
        • IEO
        • Contact:
          • Enrico Derenzini, MD
      • Napoli, Italy, 80131
        • Recruiting
        • Istituto Nazionale Tumori Di Napoli Irccs
        • Contact:
          • Anronio Pinto, MD
      • Napoli, Italy
        • Recruiting
        • AORN " A. Cardarelli"
        • Contact:
          • Ferrara Felicetto, MD
      • Orbassano, Italy
        • Recruiting
        • AUO San Luigi Gonzaga
        • Contact:
          • Alessandro Morotti, MD
      • Padova, Italy
        • Recruiting
        • Irccs Iov
        • Contact:
          • Michele Gottardi, MD
      • Palermo, Italy
        • Recruiting
        • AOU "P. Giaccone"
        • Contact:
          • Mariasanta Napolitano, MD
      • Pavia, Italy
        • Recruiting
        • Fondazione IRCCS Policlinico San Matteo
        • Contact:
          • Luca Arcaini, MD
      • Pescara, Italy
        • Recruiting
        • P.O. Santo Spirito
        • Contact:
          • Mario Di Ianni, MD
      • Ravenna, Italy, 48121
        • Recruiting
        • UO Hematology, Ospedale S. Maria delle Croci
        • Contact:
          • Francesco Lanza, MD
      • Reggio Emilia, Italy
        • Recruiting
        • Arcispedale S. Maria Nuova - AUSL IRCCS
        • Contact:
          • Annalisa Immovili, MD
      • Rimini, Italy, 47923
        • Recruiting
        • UO Hematology Ospedale Infermi
        • Contact:
          • Giulia Tolomelli, MD
      • Roma, Italy, 00168
        • Recruiting
        • IRCCS Fondazione Policlinico Universitario A. Gemelli
        • Contact:
          • Patrizia Chiusolo, MD
      • Salerno, Italy
        • Recruiting
        • AOU" San Giovanni di Dio e Ruggi d'Aragona"
        • Contact:
          • Carmine Selleri, MD
      • Torino, Italy, 10128
        • Recruiting
        • AO Ordine Mauriziano
        • Contact:
          • Carmen Fava, MD
      • Treviso, Italy, 31100
        • Recruiting
        • Ospedale Ca' Foncello Treviso
        • Contact:
          • Michele Gottardi, MD
    • FC
    • Potenza
      • Rionero In Vulture, Potenza, Italy, 85028
        • Recruiting
        • C.R.O.B. - I.R.C.C.S.
        • Contact:
          • Giuseppe Pietrantuono, MD
    • TO
      • Torino, TO, Italy, 10126
        • Recruiting
        • AOU Citta della Salute e della Scienza di Torino

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
hematologic disorder or malignancy
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
haematologic diseases characterization
Time Frame: up to 5 years
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Ex vivo Response/resistance
Time Frame: up to 5 years
To define response/resistance to ex vivo drug treatments;
up to 5 years
toxicity biomarkers identification
Time Frame: up to 5 years
To identify biomarkers of drug-related toxicity;
up to 5 years
Biological and molecular features
Time Frame: up to 5 years
To investigate association between biological and molecular features with patient's clinical features.
up to 5 years
Minimal residual disease (MRD)
Time Frame: up to 5 years
To investigate recurrence/minimal residual disease patterns after treatments
up to 5 years
Prognostic and early diagnostic biomarkers
Time Frame: up to 5 years
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.
Time Frame: up to 5 years
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
Time Frame: up to 5 years
To provide a technological advancement potentially applicable to the national health system, when properly validated in appropriate patients' subgroups.
up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Azienda Unità Sanitaria Locale della Romagna

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Giovanni Martinelli, Prof, Irst Irccs
  • Principal Investigator: Alessandro Lucchesi, MD, Irst Irccs

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 7, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 4, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 6, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 1, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 28, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRSTB100

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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