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

Not Applicable

Recruiting

• Conditions: Hematologic Diseases; Oncologic Disease
• Interventions: Other: Analysis of biological samples

• Registration Number: NCT06304194
• Lead Sponsor: Meyer Children's Hospital IRCCS

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-05
• Study First Submitted: 2024-02-23
• Status Verified: 2024-03
• Study First Submitted QC: 2024-03-04
• Last Update Submitted: 2024-03-04
• Study First Posted: 2024-03-12
• Last Update Posted: 2024-03-12
• Primary Completion: 2027-07-05
• Study Completion: 2028-07-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 340

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with suspected diagnostic onco-hematologic/immunologic disease	Analysis of biological samples	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

Primary Outcome Measures

Name	Time	Method
Appropriateness sample labelling	After 5 year from the beginning of the study	% samples correctly labelled according to IATA criteria out of total samples accepted within 48 hours
Percentage of sample suitable for RNA extraction	After 5 year from the beginning of the study	% samples suitable for RNA extraction out of total samples intended for RNA analysis
Average sample delivery time and % of accepted sample	After 5 year from the beginning of the study	average sample delivery time and % of samples accepted within 48 ±12 hours of collection out of total samples sent
Research report production time	After 5 year from the beginning of the study	research report production time (from 2 weeks for known mutation analysis to 6 months for NGS).
Quantity and quality of extracted material.	After 5 year from the beginning of the study	% of samples valid for analysis in terms of quantity of extracted material (25 ng/ul for cfDNA, 25 ng per amplicon for genomic DNA, 100 ng tot for NGS) and quality, assessed as A260/280 ratio analysis (1.8-2 per DNA).

Secondary Outcome Measures

Name	Time	Method
Genetic variants	After 5 year from the beginning of the study	% variants validated with NGS and Sanger or in two independent experiments out of the total number of variants identified
Completed patient cards	After 5 year from the beginning of the study	% of completed patient cards out of total patient cards of registered patients

Trial Locations

Locations (3)

Azienda Ospedaliero-Universitaria Pisana; 🇮🇹 Pisa, Italy

Meyer Children's Hospital IRCCS; 🇮🇹 Florence, Italy

Azienda Ospedaliero-Universitaria Senese; 🇮🇹 Siena, Italy