Molecular Characterizazion and Biological Samples Centralisation of Patients Affected by Oncoematolofic Pathology

Meyer Children's Hospital IRCCS

Status: Enrolling

Conditions: Oncologic Disease; Hematologic Diseases

Treatments: Other: Analysis of biological samples

Study type: Interventional

Funder types: Other

Identifiers

NCT06304194

BIOMARC_ONCO

Details and patient eligibility

About

Currently, the molecular characterization of onco-hematological, onco-immunological and hematological diseases, at onset or in relapse, of patients with suspected diagnosis afferent to the CROP centers, is done through centralization of biological samples at reference laboratories outside the Tuscany Region.

In order to preserve the wealth of clinical and biological data and use it for the benefit of present and future patients treated at the CROP centers, it is useful to evaluate the feasibility of centralization and molecular typing of mutations present in tumor tissue at the IRCCS AOU Meyer Oncohematology Laboratories and subsequently the analysis of clinical data from patients with diseases not under study to lay the foundations of a translational database that can then be associated with a biobank in the future.

This will enable a targeted contribution to pediatric oncohematology research, investing in possible targeted therapies with those patient subgroups that benefit from personalized disease assessment in mind. The goal of the project is to improve the regional infrastructure dedicated to organized data collection and management of biological samples in adequate time resulting in better and more comprehensive data collection.

Enrollment: 340 estimated patients

Sex: All

Ages: Under 30 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnostic suspicion of oncologic, hematologic or onco-immunologic disease
• Suspected recurrence of oncological, onco-hematological, hematological or onco -immunological disease
• Availability of biological material
• Signature of informed consent
• Age between 0 and 30 years

Exclusion criteria

• Failure to sign the consent
• Insufficiency of biological material for analysis
• Patients with HIV, HCV and HBV seropositivity (HBSAg) due to biohazard and bias related to patients' immunological status that could influence gene expression and tumor behavior.

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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340 participants in 1 patient group

Patients with suspected diagnostic onco-hematologic/immunologic disease

Other group

Description:

All patients with suspected diagnostic onco-hematologic, onco-immunologic, and hematologic disease at onset or relapse. Patients undergo several procedures to complete the diagnostic process and eventually the staging of the disease

Treatment:

Other: Analysis of biological samples