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Recruiting NCT06304194

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

No phase Interventional Oncologic Disease Hematologic Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Analysis of biological samples.
Who it may be relevant to
Registry conditions: Oncologic Disease, Hematologic Diseases. Basic parameters: 0 years — 30 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Average sample delivery time and % of accepted sample [Time frame: After 5 year from the beginning of the study]
  • Appropriateness sample labelling [Time frame: After 5 year from the beginning of the study]
  • Percentage of sample suitable for RNA extraction [Time frame: After 5 year from the beginning of the study]
  • Quantity and quality of extracted material. [Time frame: After 5 year from the beginning of the study]
  • Research report production time [Time frame: After 5 year from the beginning of the study]
Secondary outcome measures (2)
  • Genetic variants [Time frame: After 5 year from the beginning of the study]
  • Completed patient cards [Time frame: After 5 year from the beginning of the study]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Screening

Study locations

Italy · 3 centers
  • Meyer Children's Hospital IRCCS — Florence
  • Azienda Ospedaliero-Universitaria Pisana — Pisa
  • Azienda Ospedaliero-Universitaria Senese — Siena

Identifiers

NCT: NCT06304194 · BIOMARC_ONCO

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗