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

NCT ID: NCT05286138

Last Updated: 2022-04-01

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 10000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-02-01
• Study Completion Date: 2052-02-28

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.

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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Società Italiana Talassemie ed Emoglobinopatie

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

RAFFAELLA ORIGA, MD

Role: PRINCIPAL_INVESTIGATOR

Azienda Ospedaliero Universitaria di Cagliari

Locations

Azienda Ospedaliera Universitaria Di Cagliari

Cagliari, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

RAFFAELLA ORIGA, MD

Role: CONTACT

SECONDACASELLA@HOTMAIL.IT

39 070 6095655 ext. 528

Facility Contacts

RAFFAELLA ORIGA, MD

Role: primary

SECONDACASELLA@HOTMAIL.IT

+39 070 6095655 ext. -518

Other Identifiers

Tum001

Identifier Type: -

Identifier Source: org_study_id