Clinical trial NCT05286138: STUDY INCIDENCE AND CHARACTERISTICS OF MALIGNANT NEOPLASIES IN PATIENTS WITH HEMOGLOBINOPATHY FOLLOWED IN ITALY
Official title: STUDY MULTICENRIC OBSERVATIONAL, NO-PROFIT FOR THE INCIDENCE AND CHARACTERISTICS OF MALIGNANT NEOPLASIES IN PATIENTS WITH HEMOGLOBINOPATHY FOLLOWED IN ITALY
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Malignacy, Hemoglobinopathie
Lead sponsor: Società Italiana Talassemie ed Emoglobinopatie
Sponsor class: OTHER
First posted: 2022-03-18
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Living or deceased adult or pediatric (male and female) patients with transfusion-dependent (TDT) or independent (NTDT) beta-thalassemia, hemoglobin H disease, sickle cell anemia and microdrepanocytosis who have developed tumor disease during life.

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)

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

Primary outcomes:
measure: outcome 1
timeFrame: ENROLLMENT STUDY
measure: outcome 2
timeFrame: enrollment study
measure: outcome 3
timeFrame: enrollment study
Secondary outcomes:
measure: outcome 4
timeFrame: enrollment study
measure: outcome 5
timeFrame: enrollment study
measure: outcome 6
timeFrame: enrollment study
measure: outcome 7
timeFrame: enrollment study
measure: outcome 8
timeFrame: enrollment study
Other outcomes:
Locations:
city: Cagliari
country: Italy
facility: Azienda Ospedaliera Universitaria Di Cagliari
Study officials:
affiliation: Azienda Ospedaliero Universitaria di Cagliari
name: RAFFAELLA ORIGA, MD
role: PRINCIPAL_INVESTIGATOR
References: