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NCT Number: NCT05286138

STUDY 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.

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Key information

Conditions

Malignacy, Hemoglobinopathie

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Azienda Ospedaliera Universitaria Di Cagliari

Cagliari, 09121, Italy

Location status: Recruiting

Location contact

RAFFAELLA ORIGA, MD

CONTACT

[email protected]

+39 070 6095655 ext. -518

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. outcome 1

    Time frame: ENROLLMENT STUDY

    Evaluate the number of patients with hemoglobinopathy followed at Italian centers that have developed neoplastic events in the last decades

  2. outcome 2

    Time frame: enrollment study

    Evaluate which neoplasms are most associated with hemoglobinopathies

  3. outcome 3

    Time frame: enrollment study

    Identify any risk factors for the onset of neoplasms in patients with hemoglobinopathies.

Secondary outcomes

  1. outcome 4

    Time frame: enrollment study

    To highlight the differences between the various hemoglobinopathies as regards the development and characteristics of neoplastic events

  2. outcome 5

    Time frame: enrollment study

    Evaluate the possible association between neoplastic events and martial accumulation parameters in the different hemoglobinopathies

  3. outcome 6

    Time frame: enrollment study

    Evaluate the incidence and prevalence of neoplasms with respect to the total population of patients with hemoglobinopathies

  4. outcome 7

    Time frame: enrollment study

    Evaluate the impact of neoplasms as a cause of death in patients with hemoglobinopathies compared to other causes

  5. outcome 8

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

RAFFAELLA ORIGA, MD

CONTACT

[email protected]

39 070 6095655 ext. 528

Sponsors and collaborators

Lead sponsor

Società Italiana Talassemie ed Emoglobinopatie

Other

Registry information

Official study title

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

Acronym: Tum001

Important dates

Study start
2022
Primary completion
2024
Study completion
2052
First posted
Mar 18, 2022
Registry last updated
Apr 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.