STUDY INCIDENCE AND CHARACTERISTICS OF MALIGNANT NEOPLASIES IN PATIENTS WITH HEMOGLOBINOPATHY FOLLOWED IN ITALY (Tum001)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Malignacy, Hemoglobinopathie

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 Type: Observational
• Enrollment (Anticipated): 10000

Contacts and Locations

• Study Contact: Name: RAFFAELLA ORIGA, MD; Phone Number: 528 39 070 6095655; Email: SECONDACASELLA@HOTMAIL.IT

Study Locations

• Italy
  • Cagliari, Italy, 09121
    • Recruiting
    • Azienda Ospedaliera Universitaria di Cagliari
    • Contact: RAFFAELLA ORIGA, MD; Phone Number: -518 +39 070 6095655; Email: SECONDACASELLA@HOTMAIL.IT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
outcome 1	Evaluate the number of patients with hemoglobinopathy followed at Italian centers that have developed neoplastic events in the last decades	ENROLLMENT STUDY
outcome 2	Evaluate which neoplasms are most associated with hemoglobinopathies	enrollment study
outcome 3	Identify any risk factors for the onset of neoplasms in patients with hemoglobinopathies.	enrollment study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
outcome 4	To highlight the differences between the various hemoglobinopathies as regards the development and characteristics of neoplastic events	enrollment study
outcome 5	Evaluate the possible association between neoplastic events and martial accumulation parameters in the different hemoglobinopathies	enrollment study
outcome 6	Evaluate the incidence and prevalence of neoplasms with respect to the total population of patients with hemoglobinopathies	enrollment study
outcome 7	Evaluate the impact of neoplasms as a cause of death in patients with hemoglobinopathies compared to other causes	enrollment study
outcome 8	To evaluate the incidence rate of neoplasms in the total population of patients affected by hemoglobinopathies and in the various forms of hemoglobinopathy.	enrollment study

Collaborators and Investigators

• Sponsor: Società Italiana Talassemie ed Emoglobinopatie
• Investigators: Principal Investigator: RAFFAELLA ORIGA, MD, Azienda Ospedaliero Universitaria Di Cagliari

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Anticipated): February 28, 2024
• Study Completion (Anticipated): February 28, 2052

Study Registration Dates

• First Submitted: March 9, 2022
• First Submitted That Met QC Criteria: March 9, 2022
• First Posted (Actual): March 18, 2022

Study Record Updates

• Last Update Posted (Actual): April 1, 2022
• Last Update Submitted That Met QC Criteria: March 18, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Genetic Diseases, Inborn; Hemoglobinopathies
• Other Study ID Numbers: Tum001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No