STUDY INCIDENCE AND CHARACTERISTICS OF MALIGNANT NEOPLASI... | NCT05286138

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

NCT05286138

Sponsor

Società Italiana Talassemie ed Emoglobinopatie

Status

Recruiting

Last Update Posted

Apr 1, 2022Actual

Enrollment

10,000Estimated

Phase

Not provided

Conditions

Malignacy, Hemoglobinopathie

Interventions

Not provided

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2022

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2022Actual

Primary Completion Date

Feb 28, 2024Estimated

Completion Date

Feb 28, 2052Estimated

First Submitted Date

Mar 9, 2022

First Submission Date that Met QC Criteria

Mar 9, 2022

First Posted Date

Mar 18, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 18, 2022

Last Update Posted Date

Apr 1, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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)

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10,000Estimated

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
RAFFAELLA ORIGA, MD	Contact	39 070 6095655	528	SECONDACASELLA@HOTMAIL.IT

Overall Officials

Name	Affiliation	Role
RAFFAELLA ORIGA, MD	Azienda Ospedaliero Universitaria di Cagliari	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Azienda Ospedaliera Universitaria Di Cagliari	Recruiting	Cagliari		09121	Italy