Investigating cancer incidence in patients with blood disorders in Italy
STUDY MULTICENRIC OBSERVATIONAL, NO-PROFIT FOR THE INCIDENCE AND CHARACTERISTICS OF MALIGNANT NEOPLASIES IN PATIENTS WITH HEMOGLOBINOPATHY FOLLOWED IN ITALY
This study looks at how often cancer occurs in people with blood disorders like beta-thalassemia and sickle cell disease in Italy to see if there are any patterns or risk factors involved.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10000 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Società Italiana Talassemie ed Emoglobinopatie Academic / other |
| Locations | 1 site (Cagliari) |
| Trial ID | NCT05286138 on ClinicalTrials.gov |
What this trial studies
This observational study aims to gather information on the incidence and characteristics of malignant tumors in patients with hemoglobinopathies, such as beta-thalassemia and sickle cell disease, in Italy. It will assess the prevalence of various tumors, including hepatocarcinoma, and explore the relationship between tumor development and risk factors like age, sex, and iron accumulation. The study will also evaluate differences in tumor pathology across different types of hemoglobinopathy and aim to identify effective screening and prevention strategies. A substudy will further analyze the percentage of patients with hemoglobinopathy who develop tumors.
Who should consider this trial
Good fit: Ideal candidates include individuals with transfusion-dependent or independent beta-thalassemia, hemoglobin H disease, sickle cell anemia, or microdrepanocytosis who have a current or previous history of malignant tumors.
Not a fit: Patients with other hematological diseases or those without any history of neoplastic events may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early detection and prevention strategies for cancer in patients with hemoglobinopathies.
How similar studies have performed: While this study focuses on a specific population, similar studies have shown success in identifying cancer risks in patients with blood disorders, making this approach relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Transfusion-dependent or independent beta-thalassemia, hemoglobin H disease, sickle cell anemia and microdrepanocytosis * Current or previous malignant tumor pathology * Availability of medical history including the most relevant clinical and instrumental data before the onset of cancer Exclusion Criteria: * \- Other haematological diseases other than hemoglobinopathies * Absence of neoplastic events in the clinical history * Non-availability of relevant clinical and instrumental data
Where this trial is running
Cagliari
- Azienda Ospedaliera Universitaria Di Cagliari — Cagliari, Italy (Recruiting)
Study contacts
- Principal investigator: Raffaella Origa, Md — Azienda Ospedaliero Universitaria di Cagliari
- Study coordinator: Raffaella Origa, Md
- Email: SECONDACASELLA@HOTMAIL.IT
- Phone: 39 070 6095655
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.