NCT05286138

STUDY INCIDENCE AND CHARACTERISTICS OF MALIGNANT NEOPLASIES IN PATIENTS WITH HEMOGLOBINOPATHY FOLLOWED IN ITALY

STUDY MULTICENRIC OBSERVATIONAL, NO-PROFIT FOR THE INCIDENCE AND CHARACTERISTICS OF MALIGNANT NEOPLASIES IN PATIENTS WITH HEMOGLOBINOPATHY FOLLOWED IN ITALY

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 10,000 (estimated)
• Sponsor: Società Italiana Talassemie ed Emoglobinopatie · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

The Trial aims to increase the information available on the relevance of tumor pathology in hemoglobinopathies, updating the data relating to hepatocarcinoma and investigating which other tumors are more frequent in patients with hemoglobinopathies. Still, in relation to tumor pathology, the study will evaluate any differences between the different types of hemoglobinopathy and will investigate the association between the appearance of neoplasms and risk factors such as age, sex, iron accumulation markers, history of bone marrow transplant, and others.

Detailed description

By providing targeted screening strategies, these data may contribute to the early identification of tumor pathology in hemoglobinopathies, and, by contributing to the identification of risk factors, to its prevention. They will also be able to contribute to understanding which therapeutic approaches in the case of cancer are most appropriate in this category of subjects. To be able to go even deeper into understanding the possible link that exists between tumors and hemoglobinopathy, a further data collection (substudy) has been prepared in which additional and more detailed information will be collected in order to evaluate which is the percentage of patients who develop tumors compared to all those with hemoglobinopathy. The risk of developing tumors will also be assessed for each hemoglobinopathy (transfusion-dependent beta-thalassemia, transfusion independent beta-thalassemia, hemoglobin H disease, sickle cell disease, microdrepanocytosis)

Conditions

• Malignacy, Hemoglobinopathie

Timeline

• Start date: 2022-02-01
• Primary completion: 2024-02-28
• Completion: 2052-02-28
• First posted: 2022-03-18
• Last updated: 2022-04-01

Locations

1 site across 1 country: Italy