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

Hematologic Diseases Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06304194
• Other study ID #: BIOMARC_ONCO
• Status: Recruiting
• Phase: N/A
• Start date: July 5, 2023
• Est. completion date: July 5, 2028

Study information

• Verified date: March 2024
• Source: Meyer Children's Hospital IRCCS
• Contact: Marinella Veltroni
• Phone: 0555662606
• Email: marinella.veltroni[@]meyer.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 340
• Est. completion date: July 5, 2028
• Est. primary completion date: July 5, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hematologic Diseases

Intervention

Other:
• Analysis of biological samples
The collected biological sample will be isolated and the specific nucleic acid (DNA/RNA/cfDNA) extracted for molecular analysis for understanding the reproducibility of the analysis and thus the feasibility of centralization: hot spot on DNa (ddPCR/Sanger) fusion genes on RNA (target resequencing) Known mutation analysis by liquid biopsy (cfDNA) for somatic mutations with a mutation frequency of less than 10% Tumor type-associated gene sequence analysis by Sanger sequencing and NGS

Locations

Country	Name	City	State
Italy	Meyer Children's Hospital IRCCS	Florence
Italy	Azienda Ospedaliero-Universitaria Pisana	Pisa
Italy	Azienda Ospedaliero-Universitaria Senese	Siena

Sponsors (1)

Lead Sponsor	Collaborator
Meyer Children's Hospital IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average sample delivery time and % of accepted sample	average sample delivery time and % of samples accepted within 48 ±12 hours of collection out of total samples sent	After 5 year from the beginning of the study
Primary	Appropriateness sample labelling	% samples correctly labelled according to IATA criteria out of total samples accepted within 48 hours	After 5 year from the beginning of the study
Primary	Percentage of sample suitable for RNA extraction	% samples suitable for RNA extraction out of total samples intended for RNA analysis	After 5 year from the beginning of the study
Primary	Quantity and quality of extracted material.	% 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).	After 5 year from the beginning of the study
Primary	Research report production time	research report production time (from 2 weeks for known mutation analysis to 6 months for NGS).	After 5 year from the beginning of the study
Secondary	Genetic variants	% variants validated with NGS and Sanger or in two independent experiments out of the total number of variants identified	After 5 year from the beginning of the study
Secondary	Completed patient cards	% of completed patient cards out of total patient cards of registered patients	After 5 year from the beginning of the study