Actively Recruiting

Phase Not Applicable
Age: 0Years - 30Years
All Genders
ID06304194

Pilot Study to Assess Centralizing Biological Samples for Molecular Characterization in Patients with Oncohematologic Diseases Referred to CROP Centers

Led by Meyer Children's Hospital IRCCS · Updated on 2024-03-12

340

Participants Needed

3

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the feasibility of centralizing and molecularly characterizing biological samples from patients with suspected oncologic, hematologic, or onco-immunologic diseases at onset or relapse. This study aims to improve data collection and management at the IRCCS AOU Meyer Oncohematology Laboratories, supporting personalized disease assessment and targeted therapies for pediatric and young adult patients up to 30 years old. Participants suspected of having these diseases will have their biological samples collected and analyzed for molecular markers, including DNA, RNA, and circulating free DNA. Analyses involve techniques such as digital PCR, Sanger sequencing, targeted resequencing, and next-generation sequencing to detect mutations and gene fusions. This centralization process is intended to create a translational database that could be linked to a future biobank. During the study, researchers will monitor sample delivery times, labeling accuracy, suitability for RNA extraction, and the quality and quantity of extracted material. They will also track the production time of research reports and gather clinical data from patients. The study will last at least five years, focusing on enhancing regional infrastructure for timely and comprehensive clinical and biological data collection to benefit current and future patients.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 0Years - 30Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surveillance

Duration - Up to 5 years

Participants undergo diagnostic procedures and biological sample collection to assess molecular characteristics of their disease.

Visits as needed for sample collection and molecular analysis

Trial Site Locations

Total: 3 locations

1

Meyer Children's Hospital IRCCS

Florence, Italy

Actively Recruiting

2

Azienda Ospedaliero-Universitaria Pisana

Pisa, Italy

Actively Recruiting

3

Azienda Ospedaliero-Universitaria Senese

Siena, Italy

Actively Recruiting

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Research Team

M

Marinella Veltroni

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

SCREENING

Number of Arms

1

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