Breast CancerAQUANCT05960214
Cardiac Management of Patients With Thalassemia Minor and Breast Cancer
An observational study of Breast Cancer and Thalassemia Minor, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
This retrospective study aimed to evaluate the demographic characteristics, clinical conditions in term of physical examination findings), functional status, and laboratory results of patients with thalassemia minor (TM) and breast cancer (BC) in order to identify any differences between the group with BC only. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Thalassemia Minor, Heart Diseases
- How many people
- 26 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2020to 30 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with breast cancer and thalassemia minor and patients with breast cancer only.
Who may be able to join
- Patients with diagnosis of breast cancer, and thalassemia minor,
- >18 years old,
- Referred by oncologist for cardiac evaluation.
- Patients with available cardiac evaluations data at baseline and during breast cancer treatment
Who cannot join
- Patients without diagnosis of breast cancer, and thalassemia minor,
- <18 years old,
- Patients without any cardiac evaluations at baseline, and during cancer treatment.
- Patients with history of any cardiotoxic treatment prior to enrolment.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Faculty of Medicine
Fatih, Istanbul, 34093
About this study
Official title: Management of Patients With Thalassemia Minor and Breast Cancer at CardioOncology Outpatient Clinics: Age Quod Agis (AQUA)
This retrospective study aimed to evaluate the demographic characteristics, clinical conditions in term of physical examination findings), functional status, and laboratory results of patients with thalassemia minor (TM) and breast cancer (BC) in order to identify any differences between the group with BC only.
Available data as anticancer treatment, comorbidities, weight and height will be combined to report body mass index (BMI) in kg/m2, systolic and diastolic blood pressure, heart rate, ECG, transthoracic echocardiography, blood count, lipid panels, glucose, kidney function tests, (N terminal) NT-proBNP, troponins, handgrip assessments, functional status were extracted from patients files and hospital electronic archives.
Read the detailed description
Following data was extracted from files and hospital electronic records, and will be evaluated (at baseline, 3, 6, 9 and 12 months):
- Physical examination findings (as pretibial edema, jugular venous distension, lung rales),
- Clinically significant changes in cardiac function as determined by Left Ventricular Ejection Fraction (LVEF) measurements using transthoracic echocardiography,
- Any changes in (N terminal) NT-ProBNP and troponin,
- Any changes in manual handgrip measurements for both hands using hydraulic hand dynamometer,
- Applied medications, were extracted and will be evaluated.
- Conditions
- Breast Cancer, Thalassemia Minor, Heart Diseases
- Keywords
- Cardiotoxicity, Cancer treatment related cardiac dysfunctions
- Medical subject headings
- Breast Neoplasms, beta-Thalassemia, Heart Diseases, Cardiotoxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 13 pts with BC+TM | Patients diagnosed with breast cancer and thalassemia minor | |
| 13 pts with BC | Patients diagnosed with breast cancer for comparison. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of any rise in troponin
Troponin results from baseline and at 3, 6 and 12 months of cancer treatment .
Measured: From enrollment to 12 months
Incidence of any rise in NT-ProBNP
NT-ProBNP results from baseline and at 3, 6 and 12 months of cancer treatment .
Measured: From enrollment to 12 months
Incidence of any reduction in LV
Echocardiographic measurements of Left ventricle (LV) ejection fraction from baseline and at 3, 6 and 12 months of cancer treatment.
Measured: From enrollment to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2023
- Study start1 Jan 2020
- Primary completion22 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cafer Zorkun, Istanbul University
- Investigators
- Cafer Zorkun, MD PhD, Principal investigator, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05960214
- Sponsor's protocol ID
- COEXIST-3
- Acronym
- AQUA
- Status last verified
- Jul 2023
- First submitted
- 12 Jul 2023
- Last updated
- 25 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data underlying this article cannot be shared due to privacy concerns for the individuals who participated in the study. However, after obtaining proper permission from the IRB (Institutional Review Board), a summary of the data at the aggregate level, without individual identifiers, will be made available.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Patients With Thalassemia Minor and Breast Cancer at CardioOncology Outpatient Clinics: Age Quod Agis (AQUA)
- ClinicalTrials.gov ID
- NCT05960214
- Acronym / sponsor ID
- AQUA / COEXIST-3
- Conditions
- Breast Cancer, Thalassemia Minor, Heart Diseases
- Keywords
- Cardiotoxicity, Cancer treatment related cardiac dysfunctions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 22 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 25 Jul 2023 (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.
This retrospective study aimed to evaluate the demographic characteristics, clinical conditions in term of physical examination findings), functional status, and laboratory results of patients with thalassemia minor (TM) and breast cancer (BC) in order to identify any differences between the group with BC only.
Available data as anticancer treatment, comorbidities, weight and height will be combined to report body mass index (BMI) in kg/m2, systolic and diastolic blood pressure, heart rate, ECG, transthoracic echocardiography, blood count, lipid panels, glucose, kidney function tests, (N terminal) NT-proBNP, troponins, handgrip assessments, functional status were extracted from patients files and hospital electronic archives.
Detailed description
Following data was extracted from files and hospital electronic records, and will be evaluated (at baseline, 3, 6, 9 and 12 months):
- Physical examination findings (as pretibial edema, jugular venous distension, lung rales),
- Clinically significant changes in cardiac function as determined by Left Ventricular Ejection Fraction (LVEF) measurements using transthoracic echocardiography,
- Any changes in (N terminal) NT-ProBNP and troponin,
- Any changes in manual handgrip measurements for both hands using hydraulic hand dynamometer,
- Applied medications, were extracted and will be evaluated.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 13 pts with BC+TM | – | –Patients diagnosed with breast cancer and thalassemia minor |
| 13 pts with BC | – | –Patients diagnosed with breast cancer for comparison. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with breast cancer and thalassemia minor and patients with breast cancer only.
Key inclusion criteria (4 listed)
- Patients with diagnosis of breast cancer, and thalassemia minor,
- >18 years old,
- Referred by oncologist for cardiac evaluation.
- Patients with available cardiac evaluations data at baseline and during breast cancer treatment
Key exclusion criteria (4 listed)
- Patients without diagnosis of breast cancer, and thalassemia minor,
- <18 years old,
- Patients without any cardiac evaluations at baseline, and during cancer treatment.
- Patients with history of any cardiotoxic treatment prior to enrolment.
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
Incidence of any rise in troponin
Time frame: From enrollment to 12 months
Troponin results from baseline and at 3, 6 and 12 months of cancer treatment .
Incidence of any rise in NT-ProBNP
Time frame: From enrollment to 12 months
NT-ProBNP results from baseline and at 3, 6 and 12 months of cancer treatment .
Incidence of any reduction in LV
Time frame: From enrollment to 12 months
Echocardiographic measurements of Left ventricle (LV) ejection fraction from baseline and at 3, 6 and 12 months of cancer treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2023.
- Individual participant dataSharing planned: Undecided. The data underlying this article cannot be shared due to privacy concerns for the individuals who participated in the study. However, after obtaining proper permission from the IRB (Institutional Review Board), a summary of the data at the aggregate level, without individual identifiers, will be made available.
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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. This study is not recruiting at the moment.
Cafer Zorkun, MD PhD principal investigator
Istanbul University
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 Breast Cancer and Thalassemia Minor, run by Istanbul University at 1 site in Turkey (Türkiye).
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 25 Jul 2023. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of any rise in troponin (time frame: From enrollment to 12 months). 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 25 Jul 2023.