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

18 mars 2022 uppdaterad av: Società Italiana Talassemie ed Emoglobinopatie

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.

Studieöversikt

Status

Rekrytering

Betingelser

Malignacy, Hemoglobinopathie

Detaljerad beskrivning

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)

Studietyp

Observationell

Inskrivning (Förväntat)

10000

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Namn: RAFFAELLA ORIGA, MD
Telefonnummer: 528 39 070 6095655
E-post: SECONDACASELLA@HOTMAIL.IT

Studieorter

Italien
- - Cagliari, Italien, 09121
    - Rekrytering
    - Azienda Ospedaliera Universitaria di Cagliari
    - Kontakt:
      
      RAFFAELLA ORIGA, MD
      
      Telefonnummer: -518 +39 070 6095655
      
      E-post: SECONDACASELLA@HOTMAIL.IT

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 100 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Vad mäter studien?

Primära resultatmått

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

Sekundära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
outcome 4 Tidsram: enrollment study	To highlight the differences between the various hemoglobinopathies as regards the development and characteristics of neoplastic events	enrollment study
outcome 5 Tidsram: enrollment study	Evaluate the possible association between neoplastic events and martial accumulation parameters in the different hemoglobinopathies	enrollment study
outcome 6 Tidsram: enrollment study	Evaluate the incidence and prevalence of neoplasms with respect to the total population of patients with hemoglobinopathies	enrollment study
outcome 7 Tidsram: enrollment study	Evaluate the impact of neoplasms as a cause of death in patients with hemoglobinopathies compared to other causes	enrollment study
outcome 8 Tidsram: 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.	enrollment study

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Società Italiana Talassemie ed Emoglobinopatie

Utredare

Huvudutredare: RAFFAELLA ORIGA, MD, Azienda Ospedaliero Universitaria di Cagliari

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 februari 2022

Primärt slutförande (Förväntat)

28 februari 2024

Avslutad studie (Förväntat)

28 februari 2052

Studieregistreringsdatum

Först inskickad

9 mars 2022

Först inskickad som uppfyllde QC-kriterierna