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

NCT05286138 | Recruiting

• 1 other identifier: Tum001
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignacy, Hemoglobinopathie

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• outcome 4

  enrollment study

• outcome 5

  enrollment study

• outcome 6

  enrollment study

• outcome 7

  enrollment study

• outcome 8

  enrollment study

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• \- Other haematological diseases other than hemoglobinopathies
• Absence of neoplastic events in the clinical history
• Non-availability of relevant clinical and instrumental data

Sponsors & Collaborators

• Società Italiana Talassemie ed Emoglobinopatie: lead

Study Sites (1)

Azienda Ospedaliera Universitaria Di Cagliari

Cagliari, 09121, Italy

RECRUITING

Study Officials

• RAFFAELLA ORIGA, MD

  Azienda Ospedaliero Universitaria di Cagliari

  PRINCIPAL INVESTIGATOR

Central Study Contacts

RAFFAELLA ORIGA, MD

CONTACT

39 070 6095655; SECONDACASELLA@HOTMAIL.IT

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2022
• First Posted: March 18, 2022
• Study Start: February 1, 2022
• Primary Completion: February 28, 2024
• Study Completion (Estimated): February 28, 2052
• Last Updated: April 1, 2022

Record last verified: 2022-03

Locations

IT (1)