Acute LeukemiaIT-TCP POSNCT07403630
INTEGRATIVE "MULTI-OMICS" AND FUNCTIONAL PLATFORM FOR THE COMPLETE DIAGNOSTIC CHARACTERIZATION OF TUMORS: THE ITALIAN TUMOR CHEMOGENOMIC PROFILER (IT-TCP)
A study testing Functional tests, Multi-omics analyses and Cytogenetics/ FISH in people with Acute Leukemia and Multiple Myeloma, run by Azienda Ospedaliero-Universitaria di Parma at 2 sites in Italy.
Trial summary
This is a multicenter, experimental preclinical study conducted on primary samples from patients diagnosed with hematological or solid neoplasms defined as high risk. The study will be prospective, based on the consecutive enrollment of eligible patients at each participating institution. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Acute Leukemia, Multiple Myeloma, Squamous Cell Carcinoma
- What is being tested?
- Functional tests, Multi-omics analyses and Cytogenetics/ FISH
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesItaly
- Study dates
- 31 May 2023to 12 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients aged one year and over who are referred to the centres involved in the protocol (Azienda Ospedaliero-Universitaria di Parma, University of Parma, University of Perugia and Azienda Ospedali Riuniti Villa Sofia-Cervello of Palermo).
- Patients with an established diagnosis of haematological or solid organ malignancy, including haematological or solid malignancies characteristic of the paediatric age group.
- Patients diagnosed with relapsed, refractory and/or metastatic haematological or solid malignancy. Patients may be enrolled regardless of the extent and type of previous therapy. Patients may also be enrolled if they are undergoing active treatment at the time of evaluation.
- Patients must have the capacity to understand the investigative nature of the study and provide informed consent in writing. For patients under the age of 12 years, consent will be provided by the parent/legal guardian according to international guidelines. For patients aged 12 to 17 years, consent will be provided by the patient and the parent/legal guardian according to the mature minor principle.
Who cannot join
- Patients younger than 1 year old
- Patients with active, uncontrolled infections
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites, 2 recruiting
- Recruiting
AO Riuniti Villa Sofia-Cervello di Palermo
Palermo, Palermo, 90146
Alessandra Santoro, + 39 091-7803143, alessandra.santoro01@unipa.it
- Recruiting
University of Perugia
Perugia, Perugia, 06123
Roberta La Starza, Medical doctor, PhD, +39 075 5783455, roberta.lastarza@unipg.it
About this study
This is a multicenter, experimental preclinical study conducted on primary samples from patients diagnosed with hematological or solid neoplasms defined as high risk. The study will be prospective, based on the consecutive enrollment of eligible patients at each participating institution.
Read the detailed description
This pre-clinical, experimental study will involve primary samples from patients diagnosed with haematological or solid neoplasms defined as high-risk.
It will be prospective, based on consecutive enrolment of eligible patients at each participating institution. Patients will be enrolled based on their biological and clinical characteristics at the time of diagnosis. This will include patients with metastatic disease, as well as those with recurrent or refractory disease, particularly where the therapeutic indication is not supported by internationally recognised guidelines.
- Conditions
- Acute Leukemia, Multiple Myeloma, Squamous Cell Carcinoma, Pleural Mesothelioma, Pancreatic Cancer, Bladder Cancer
- Being tested
- Functional tests, Multi-omics analyses, Cytogenetics/ FISH
- Medical subject headings
- Multiple Myeloma, Carcinoma, Squamous Cell, Mesothelioma, Malignant, Pancreatic Neoplasms, Urinary Bladder Neoplasms, Ovarian Neoplasms, Melanoma, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional testsBiological
Functional analyses will be performed on primary sample from each enrolled patient. Malignant cells are cultered and incubated with a specific library of drugs (300 drugs) at four different concentrations for 72 hours.
Multi-omics analysesOther
Our scientific approach is based on various investigations, including radiomics, digital pathology, immune profiling, bulk transcriptomics, single-cell resolution, single-cell transcriptomics, phosphoproteomics, functional immunoprofiling, and inflammasome analysis, NGS (Next Generation Sequencing analysis).
Cytogenetics/ FISHGenetic
Individual biopsy samples will be evaluated in a pipeline that includes established diagnostic elements, e.g., cytogenetics and FISH.
| Study group | Role | What they receive |
|---|---|---|
| Haematological neoplasms or neoplasms of solid organs | Other | * Patients with a confirmed diagnosis of hematological malignancy or solid organ malignancy, including solid or hematological malignancies characteristic of pediatric age.
* Patients diagnosed with hematological or solid neoplasms defined as high risk, according to biological and clinical characteristics, including metastatic cases, or diagnosed with recurrent and/or refractory hematological or solid neoplasms. Receives: Biological: Functional tests; Other: Multi-omics analyses; Genetic: Cytogenetics/ FISH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the rate of change in therapeutic indication of disease from standard-of-care.
Measured: At baseline
Secondary outcomes (2)
Evaluation of the possible use of the IT-TCP platform on the clinical level
Measured: At baseline
Creation of an IT platform to store and manage the data generated
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start31 May 2023
- Primary completionFeb 2027 (estimated)
- Study completion12 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria di Parma
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giovanni Roti, University of Parma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07403630
- Sponsor's protocol ID
- 5756
- Acronym
- IT-TCP POS
- Status last verified
- Feb 2026
- First submitted
- 4 Feb 2026
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INTEGRATIVE "MULTI-OMICS" AND FUNCTIONAL PLATFORM FOR THE COMPLETE DIAGNOSTIC CHARACTERIZATION OF TUMORS: THE ITALIAN TUMOR CHEMOGENOMIC PROFILER (IT-TCP)
- ClinicalTrials.gov ID
- NCT07403630
- Acronym / sponsor ID
- IT-TCP POS / 5756
- Conditions
- Acute Leukemia, Multiple Myeloma, Squamous Cell Carcinoma, Pleural Mesothelioma, Pancreatic Cancer, Bladder Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero-Universitaria di ParmaUniversity, hospital or other
- Study start
- 31 May 2023 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- 12 Feb 2028 (estimated)
- First posted
- 11 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, experimental preclinical study conducted on primary samples from patients diagnosed with hematological or solid neoplasms defined as high risk. The study will be prospective, based on the consecutive enrollment of eligible patients at each participating institution.
Detailed description
This pre-clinical, experimental study will involve primary samples from patients diagnosed with haematological or solid neoplasms defined as high-risk.
It will be prospective, based on consecutive enrolment of eligible patients at each participating institution. Patients will be enrolled based on their biological and clinical characteristics at the time of diagnosis. This will include patients with metastatic disease, as well as those with recurrent or refractory disease, particularly where the therapeutic indication is not supported by internationally recognised guidelines.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Haematological neoplasms or neoplasms of solid organs | Other | Biological: Functional tests, Other: Multi-omics analyses, Genetic: Cytogenetics/ FISH* Patients with a confirmed diagnosis of hematological malignancy or solid organ malignancy, including solid or hematological malignancies characteristic of pediatric age. * Patients diagnosed with hematological or solid neoplasms defined as high risk, according to biological and clinical characteristics, including metastatic cases, or diagnosed with recurrent and/or refractory hematological or solid neoplasms. |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged one year and over who are referred to the centres involved in the protocol (Azienda Ospedaliero-Universitaria di Parma, University of Parma, University of Perugia and Azienda Ospedali Riuniti Villa Sofia-Cervello of Palermo).
- Patients with an established diagnosis of haematological or solid organ malignancy, including haematological or solid malignancies characteristic of the paediatric age group.
- Patients diagnosed with relapsed, refractory and/or metastatic haematological or solid malignancy. Patients may be enrolled regardless of the extent and type of previous therapy. Patients may also be enrolled if they are undergoing active treatment at the time of evaluation.
- Patients must have the capacity to understand the investigative nature of the study and provide informed consent in writing. For patients under the age of 12 years, consent will be provided by the parent/legal guardian according to international guidelines. For patients aged 12 to 17 years, consent will be provided by the patient and the parent/legal guardian according to the mature minor principle.
Key exclusion criteria (2 listed)
- Patients younger than 1 year old
- Patients with active, uncontrolled infections
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional testsFunctional analyses will be performed on primary sample from each enrolled patient. Malignant cells are cultered and incubated with a specific library of drugs (300 drugs) at four different concentrations for 72 hours. | Biological | Haematological neoplasms or neoplasms of solid organs |
| Multi-omics analysesOur scientific approach is based on various investigations, including radiomics, digital pathology, immune profiling, bulk transcriptomics, single-cell resolution, single-cell transcriptomics, phosphoproteomics, functional immunoprofiling, and inflammasome analysis, NGS (Next Generation Sequencing analysis). | Other | Haematological neoplasms or neoplasms of solid organs |
| Cytogenetics/ FISHIndividual biopsy samples will be evaluated in a pipeline that includes established diagnostic elements, e.g., cytogenetics and FISH. | Genetic | Haematological neoplasms or neoplasms of solid organs |
Primary outcome
Evaluation of the rate of change in therapeutic indication of disease from standard-of-care.
Time frame: At baseline
2 secondary outcomes
Evaluation of the possible use of the IT-TCP platform on the clinical level
Time frame: At baseline
Creation of an IT platform to store and manage the data generated
Time frame: At baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional tests, Multi-omics analyses and Cytogenetics/ FISH in people with Acute Leukemia and Multiple Myeloma, run by Azienda Ospedaliero-Universitaria di Parma at 2 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 4 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giovanni Roti, Associate Professor (+39 0521 702200, giovanni.roti@unipr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the rate of change in therapeutic indication of disease from standard-of-care. (time frame: At baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Feb 2026.