Centralizing biological samples for patients with blood cancers
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
This study is trying to collect and analyze blood samples from young patients with blood cancers to help improve treatments and research for these conditions.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 340 (estimated) |
| Ages | 0 Years to 30 Years |
| Sex | All |
| Sponsor | Meyer Children's Hospital IRCCS Academic / other |
| Locations | 3 sites (Florence and 2 other locations) |
| Trial ID | NCT06304194 on ClinicalTrials.gov |
What this trial studies
This study focuses on the molecular characterization of onco-hematological and hematological diseases in patients suspected of having these conditions. It aims to centralize biological samples at the IRCCS AOU Meyer Oncohematology Laboratories to facilitate the analysis of mutations in tumor tissue. By collecting and analyzing clinical data, the study seeks to establish a translational database that could support future pediatric oncohematology research and targeted therapies. The initiative is particularly aimed at enhancing the treatment of patients aged 0 to 30 years.
Who should consider this trial
Good fit: Ideal candidates for this study are patients aged 0 to 30 years with a diagnostic suspicion or recurrence of oncologic, hematologic, or onco-immunologic diseases.
Not a fit: Patients who may not benefit from this study include those with insufficient biological material for analysis or those with HIV, HCV, or HBV seropositivity.
Why it matters
Potential benefit: If successful, this study could lead to improved targeted therapies for pediatric patients with oncohematological diseases.
How similar studies have performed: While this approach is innovative in its focus on pediatric oncohematology, similar studies have shown promise in the centralization and molecular analysis of cancer samples.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Florence and 2 other locations
- Meyer Children's Hospital IRCCS — Florence, Italy (Recruiting)
- Azienda Ospedaliero-Universitaria Pisana — Pisa, Italy (Recruiting)
- Azienda Ospedaliero-Universitaria Senese — Siena, Italy (Recruiting)
Study contacts
- Principal investigator: Marinella Veltroni — Meyer Children's Hospital IRCCS
- Study coordinator: Marinella Veltroni
- Email: marinella.veltroni@meyer.it
- Phone: 0555662606
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.