Clinical trial NCT06304194: Molecular Characterizazion and Biological Samples Centralisation of Patients Affected by Oncoematolofic Pathology
Official title: Pilot Study to Assess the Feasibility of Centralizing Biological Samples at Onset and Relapse of Patients Referred to CROP Centers for Molecular Characterization of Oncohematologic Pathology
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Oncologic Disease
Hematologic Diseases
Lead sponsor: Meyer Children's Hospital IRCCS
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 340
Sex: ALL
Minimum age (years): 0
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Average sample delivery time and % of accepted sample
timeFrame: After 5 year from the beginning of the study
measure: Appropriateness sample labelling
timeFrame: After 5 year from the beginning of the study
measure: Percentage of sample suitable for RNA extraction
timeFrame: After 5 year from the beginning of the study
measure: Quantity and quality of extracted material.
timeFrame: After 5 year from the beginning of the study
measure: Research report production time
timeFrame: After 5 year from the beginning of the study
Secondary outcomes:
measure: Genetic variants
timeFrame: After 5 year from the beginning of the study
measure: Completed patient cards
timeFrame: After 5 year from the beginning of the study
Other outcomes:
Locations:
city: Florence
country: Italy
facility: Meyer Children's Hospital IRCCS
city: Pisa
country: Italy
facility: Azienda Ospedaliero-Universitaria Pisana
city: Siena
country: Italy
facility: Azienda Ospedaliero-Universitaria Senese
Study officials:
affiliation: Meyer Children's Hospital IRCCS
name: Marinella Veltroni
role: PRINCIPAL_INVESTIGATOR
References: