Tum001: STUDY INCIDENCE AND CHARACTERISTICS OF MALIGNANT NEOPLASIES IN PATIENTS WITH HEMOGLOBINOPATHY FOLLOWED IN ITALY
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
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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)
Study Design
Outcome Measures
Primary Outcome Measures
- outcome 1 [ENROLLMENT STUDY]
Evaluate the number of patients with hemoglobinopathy followed at Italian centers that have developed neoplastic events in the last decades
- outcome 2 [enrollment study]
Evaluate which neoplasms are most associated with hemoglobinopathies
- outcome 3 [enrollment study]
Identify any risk factors for the onset of neoplasms in patients with hemoglobinopathies.
Secondary Outcome Measures
- outcome 4 [enrollment study]
To highlight the differences between the various hemoglobinopathies as regards the development and characteristics of neoplastic events
- outcome 5 [enrollment study]
Evaluate the possible association between neoplastic events and martial accumulation parameters in the different hemoglobinopathies
- outcome 6 [enrollment study]
Evaluate the incidence and prevalence of neoplasms with respect to the total population of patients with hemoglobinopathies
- outcome 7 [enrollment study]
Evaluate the impact of neoplasms as a cause of death in patients with hemoglobinopathies compared to other causes
- outcome 8 [enrollment study]
To evaluate the incidence rate of neoplasms in the total population of patients affected by hemoglobinopathies and in the various forms of hemoglobinopathy.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Transfusion-dependent or independent beta-thalassemia, hemoglobin H disease, sickle cell anemia and microdrepanocytosis
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Current or previous malignant tumor pathology
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Availability of medical history including the most relevant clinical and instrumental data before the onset of cancer
Exclusion Criteria:
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- Other haematological diseases other than hemoglobinopathies
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Absence of neoplastic events in the clinical history
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Non-availability of relevant clinical and instrumental data
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Azienda Ospedaliera Universitaria Di Cagliari | Cagliari | Italy | 09121 |
Sponsors and Collaborators
- Società Italiana Talassemie ed Emoglobinopatie
Investigators
- Principal Investigator: RAFFAELLA ORIGA, MD, Azienda Ospedaliero Universitaria di Cagliari
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Tum001