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NCT Number: NCT06304194

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

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.

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Key information

Age range

0 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Meyer Children's Hospital IRCCS, Florence, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Analysis of biological samples

Other

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 outcomes

  1. Average sample delivery time and % of accepted sample

    Time frame: 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

  2. Appropriateness sample labelling

    Time frame: After 5 year from the beginning of the study

    % samples correctly labelled according to IATA criteria out of total samples accepted within 48 hours

  3. Percentage of sample suitable for RNA extraction

    Time frame: After 5 year from the beginning of the study

    % samples suitable for RNA extraction out of total samples intended for RNA analysis

  4. Quantity and quality of extracted material.

    Time frame: 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).

  5. Research report production time

    Time frame: 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).

Secondary outcomes

  1. Genetic variants

    Time frame: 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

  2. Completed patient cards

    Time frame: After 5 year from the beginning of the study

    % of completed patient cards out of total patient cards of registered patients

Study contacts

Contact information is provided by the study sponsor or research team.

Marinella Veltroni

CONTACT

[email protected]

0555662606

Sponsors and collaborators

Lead sponsor

Meyer Children's Hospital IRCCS

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Mar 12, 2024
Registry last updated
Mar 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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