STUDY INCIDENCE AND CHARACTERISTICS OF MALIGNANT NEOPLASIES IN PATIENTS WITH HEMOGLOBINOPATHY FOLLOWED IN ITALY (Tum001)
18. marts 2022 opdateret af: 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.
Studieoversigt
Status
Rekruttering
Betingelser
Detaljeret beskrivelse
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)
Undersøgelsestype
Observationel
Tilmelding (Forventet)
10000
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: RAFFAELLA ORIGA, MD
- Telefonnummer: 528 39 070 6095655
- E-mail: SECONDACASELLA@HOTMAIL.IT
Studiesteder
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Cagliari, Italien, 09121
- Rekruttering
- Azienda Ospedaliera Universitaria di Cagliari
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Kontakt:
- RAFFAELLA ORIGA, MD
- Telefonnummer: -518 +39 070 6095655
- E-mail: SECONDACASELLA@HOTMAIL.IT
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 100 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
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.
Beskrivelse
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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outcome 1
Tidsramme: ENROLLMENT STUDY
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Evaluate the number of patients with hemoglobinopathy followed at Italian centers that have developed neoplastic events in the last decades
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ENROLLMENT STUDY
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outcome 2
Tidsramme: enrollment study
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Evaluate which neoplasms are most associated with hemoglobinopathies
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enrollment study
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outcome 3
Tidsramme: enrollment study
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Identify any risk factors for the onset of neoplasms in patients with hemoglobinopathies.
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enrollment study
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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outcome 4
Tidsramme: enrollment study
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To highlight the differences between the various hemoglobinopathies as regards the development and characteristics of neoplastic events
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enrollment study
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outcome 5
Tidsramme: enrollment study
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Evaluate the possible association between neoplastic events and martial accumulation parameters in the different hemoglobinopathies
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enrollment study
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outcome 6
Tidsramme: enrollment study
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Evaluate the incidence and prevalence of neoplasms with respect to the total population of patients with hemoglobinopathies
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enrollment study
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outcome 7
Tidsramme: enrollment study
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Evaluate the impact of neoplasms as a cause of death in patients with hemoglobinopathies compared to other causes
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enrollment study
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outcome 8
Tidsramme: enrollment study
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To evaluate the incidence rate of neoplasms in the total population of patients affected by hemoglobinopathies and in the various forms of hemoglobinopathy.
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enrollment study
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: RAFFAELLA ORIGA, MD, Azienda Ospedaliero Universitaria di Cagliari
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. februar 2022
Primær færdiggørelse (Forventet)
28. februar 2024
Studieafslutning (Forventet)
28. februar 2052
Datoer for studieregistrering
Først indsendt
9. marts 2022
Først indsendt, der opfyldte QC-kriterier
9. marts 2022
Først opslået (Faktiske)
18. marts 2022
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
1. april 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
18. marts 2022
Sidst verificeret
1. marts 2022
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Tum001
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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