Malignacy, HemoglobinopathieTum001NCT05286138
STUDY INCIDENCE AND CHARACTERISTICS OF MALIGNANT NEOPLASIES IN PATIENTS WITH HEMOGLOBINOPATHY FOLLOWED IN ITALY
An observational study of Malignacy, Hemoglobinopathie, run by Società Italiana Talassemie ed Emoglobinopatie at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Malignacy, Hemoglobinopathie
- How many people
- 10,000 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2022to 28 Feb 2052
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older 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.
Who may be able to join
- 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
Who cannot join
- - Other haematological diseases other than hemoglobinopathies
- Absence of neoplastic events in the clinical history
- Non-availability of relevant clinical and instrumental data
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Azienda Ospedaliera Universitaria Di Cagliari
Cagliari, 09121
RAFFAELLA ORIGA, MD, +39 070 6095655 ext. -518, SECONDACASELLA@HOTMAIL.IT
About this study
Official title: 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.
Read the 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)
- Conditions
- Malignacy, Hemoglobinopathie
What is being measured
The primary outcome is the main question the study is designed to answer.
outcome 1
Evaluate the number of patients with hemoglobinopathy followed at Italian centers that have developed neoplastic events in the last decades
Measured: ENROLLMENT STUDY
outcome 2
Evaluate which neoplasms are most associated with hemoglobinopathies
Measured: enrollment study
outcome 3
Identify any risk factors for the onset of neoplasms in patients with hemoglobinopathies.
Measured: enrollment study
Secondary outcomes (5)
outcome 4
To highlight the differences between the various hemoglobinopathies as regards the development and characteristics of neoplastic events
Measured: enrollment study
outcome 5
Evaluate the possible association between neoplastic events and martial accumulation parameters in the different hemoglobinopathies
Measured: enrollment study
outcome 6
Evaluate the incidence and prevalence of neoplasms with respect to the total population of patients with hemoglobinopathies
Measured: enrollment study
outcome 7
Evaluate the impact of neoplasms as a cause of death in patients with hemoglobinopathies compared to other causes
Measured: enrollment study
outcome 8
To evaluate the incidence rate of neoplasms in the total population of patients affected by hemoglobinopathies and in the various forms of hemoglobinopathy.
Measured: enrollment study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start1 Feb 2022
- Primary completion28 Feb 2024 (estimated)
- Study completion28 Feb 2052 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignacy, HemoglobinopathieStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Società Italiana Talassemie ed Emoglobinopatie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- RAFFAELLA ORIGA, MD, Principal investigator, Azienda Ospedaliero Universitaria di Cagliari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05286138
- Sponsor's protocol ID
- Tum001
- Acronym
- Tum001
- Status last verified
- Mar 2022
- First submitted
- 9 Mar 2022
- Last updated
- 1 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STUDY MULTICENRIC OBSERVATIONAL, NO-PROFIT FOR THE INCIDENCE AND CHARACTERISTICS OF MALIGNANT NEOPLASIES IN PATIENTS WITH HEMOGLOBINOPATHY FOLLOWED IN ITALY
- ClinicalTrials.gov ID
- NCT05286138
- Acronym / sponsor ID
- Tum001 / Tum001
- Conditions
- Malignacy, Hemoglobinopathie
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Società Italiana Talassemie ed EmoglobinopatieUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 28 Feb 2024 (estimated)
- Study completion
- 28 Feb 2052 (estimated)
- First posted
- 18 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- - Other haematological diseases other than hemoglobinopathies
- Absence of neoplastic events in the clinical history
- Non-availability of relevant clinical and instrumental data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
outcome 2
Time frame: enrollment study
Evaluate which neoplasms are most associated with hemoglobinopathies
outcome 3
Time frame: enrollment study
Identify any risk factors for the onset of neoplasms in patients with hemoglobinopathies.
5 secondary outcomes
outcome 4
Time frame: enrollment study
outcome 5
Time frame: enrollment study
outcome 6
Time frame: enrollment study
outcome 7
Time frame: enrollment study
outcome 8
Time frame: enrollment study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2022.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
RAFFAELLA ORIGA, MD principal investigator
Azienda Ospedaliero Universitaria di Cagliari
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malignacy, Hemoglobinopathie, run by Società Italiana Talassemie ed Emoglobinopatie at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact RAFFAELLA ORIGA, MD (39 070 6095655 ext. 528, SECONDACASELLA@HOTMAIL.IT), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
outcome 1 (time frame: ENROLLMENT STUDY). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2022.