NCT07403630
Recruiting
Not Applicable
INTEGRATIVE "MULTI-OMICS" AND FUNCTIONAL PLATFORM FOR THE COMPLETE DIAGNOSTIC CHARACTERIZATION OF TUMORS: THE ITALIAN TUMOR CHEMOGENOMIC PROFILER (IT-TCP)
Azienda Ospedaliero-Universitaria di Parma2 sites in 1 country300 target enrollmentStarted: May 31, 2023Last updated:
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 300
- Locations
- 2
- Primary Endpoint
- Evaluation of the rate of change in therapeutic indication of disease from standard-of-care.
Overview
Brief 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.
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
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 1 Year to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •Patients younger than 1 year old
- •Patients with active, uncontrolled infections
Arms & Interventions
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.
Intervention: Functional tests (Biological)
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.
Intervention: Multi-omics analyses (Other)
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.
Intervention: Cytogenetics/ FISH (Genetic)
Outcomes
Primary Outcomes
Evaluation of the rate of change in therapeutic indication of disease from standard-of-care.
Time Frame: At baseline
Secondary Outcomes
- Evaluation of the possible use of the IT-TCP platform on the clinical level(At baseline)
- Creation of an IT platform to store and manage the data generated(At baseline)
Investigators
Giovanni Roti
Full Professor
University of Parma
Study Sites (2)
Loading locations...
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