Actively Recruiting
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
Eligibility Criteria
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
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
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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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