2D Speckle Tracking EchocardiographyNCT06206395
Role of Multi-modality Imaging in the Assessment of Chemotherapy Related Cardiac Dysfunction Among Cancer Patients
An observational study of 2D Speckle Tracking Echocardiography and Breast Cancer, run by Assiut University at 1 site in Egypt.
Trial summary
The field of oncology has advanced remarkably. Some of the old and new emerging cancer therapies are associated with development of cardiovascular toxicities , which may have the potential to offset the gains in survival obtained with this cancer treatment advances. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- 2D Speckle Tracking Echocardiography, Breast Cancer, Cardiac Magnetic Resonance
- What is being tested?
- Two dimensions speckle tracking and three dimension echocardiography and cardiac magnetic resonance imaging
- Type of treatment
- Medical device
- How many people
- 190 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2024to 1 May 2025
- How long will I take part?
- 1 Year
- 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: Cancer patients receiving chemotherapeutic drugs with or without adjuvant radiotherapy at oncology department of Assiut University Hospital will be enrolled and imaging modalities will be performed at Assiut University Heart Hospital.
Who may be able to join
- Cancer patients ≥ 18 years of age, and scheduled to receive chemotherapy will be included.
Who cannot join
- Contraindications to CMR (e.g.: patients with pacemakers, defibrillators or other implanted electronic devices).
- Life expectancy ≤ 12 months.
- Participating in another oncology clinical trial;
- Prior exposure to chemotherapy;
- History of active or prior cardiac disease (e.g., myocardial infarction, heart failure or base line left ventricular ejection fraction less than 55%).
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Assiut University-Cardiovascular department
Asyut, 71515
John S Johny, MSC, 01201045287, johnsafwatjohny91@yahoo.com
Shaima S Hassan, 01001346551, shaimaakhidr@gmail.com
About this study
Official title: Assiut University-Egypt
The field of oncology has advanced remarkably. Some of the old and new emerging cancer therapies are associated with development of cardiovascular toxicities , which may have the potential to offset the gains in survival obtained with this cancer treatment advances. Much of the focus on cardiovascular toxicities has been in the early detection of myocardial damage and prediction of cancer therapeutics-related cardiac dysfunction (CTRCD). The main strategy for these patients is timely diagnosis and treatment of high-risk individual Cardiac dysfunction associated with cancer treatment is the main cause of mortality in cancer survivors. The mortality rate is recorded to be up to 60% in the first two years after therapy. The most commonly associated drugs with cardiotoxicity are anthracycline (AC) and monoclonal antibodies (such as trastuzumab). Other new agents, such as vascular endothelial growth factor (VEGF) inhibitors, immunotherapies, and proteasome inhibitors, can also cause cardiac dysfunction .
- Being tested
- Two dimensions speckle tracking and three dimension echocardiography and cardiac magnetic resonance imaging
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Two dimensions speckle tracking and three dimension echocardiography and cardiac magnetic resonance imagingDevice
2D speckle tracking echo will be performed before chemotherapy and after mid-cycle and after completion of treatment.
3D echo and CMR will be performed before and after chemotherapy treatment.
| Study group | Role | What they receive |
|---|---|---|
| Cancer patients receiving chemotherapeutic drugs | Cancer patients ≥ 18 years of age, and scheduled to receive chemotherapy will be included. Receives: Device: Two dimensions speckle tracking and three dimension echocardiography and cardiac magnetic resonance imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine and compare the role of 2D speckle tracking vs. 3D echocardiography in assessment of early LV systolic dysfunction in patients receiving different chemotherapy combinations
All patient will be undergo both 2D and 3D echocardiography before and after treatment to detect early LV systolic dysfunction.
Measured: up to 6 months after starting chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study start1 Feb 2024 (estimated)
- Primary completion1 Mar 2025 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 2D Speckle Tracking EchocardiographyStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 190 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Safwat Johny, Assiut University
- Investigators
- John S Johny, MSC, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06206395
- Sponsor's protocol ID
- Cardiotoxicity and cancer
- Status last verified
- Jan 2024
- First submitted
- 25 Sep 2023
- Last updated
- 16 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assiut University-Egypt
- ClinicalTrials.gov ID
- NCT06206395
- Acronym / sponsor ID
- Cardiotoxicity and cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (estimated)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 16 Jan 2024 (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 field of oncology has advanced remarkably. Some of the old and new emerging cancer therapies are associated with development of cardiovascular toxicities , which may have the potential to offset the gains in survival obtained with this cancer treatment advances. Much of the focus on cardiovascular toxicities has been in the early detection of myocardial damage and prediction of cancer therapeutics-related cardiac dysfunction (CTRCD). The main strategy for these patients is timely diagnosis and treatment of high-risk individual Cardiac dysfunction associated with cancer treatment is the main cause of mortality in cancer survivors. The mortality rate is recorded to be up to 60% in the first two years after therapy. The most commonly associated drugs with cardiotoxicity are anthracycline (AC) and monoclonal antibodies (such as trastuzumab). Other new agents, such as vascular endothelial growth factor (VEGF) inhibitors, immunotherapies, and proteasome inhibitors, can also cause cardiac dysfunction .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cancer patients receiving chemotherapeutic drugs | – | Device: Two dimensions speckle tracking and three dimension echocardiography and cardiac magnetic resonance imagingCancer patients ≥ 18 years of age, and scheduled to receive chemotherapy will be included. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cancer patients receiving chemotherapeutic drugs with or without adjuvant radiotherapy at oncology department of Assiut University Hospital will be enrolled and imaging modalities will be performed at Assiut University Heart Hospital.
Key inclusion criteria (1 listed)
- Cancer patients ≥ 18 years of age, and scheduled to receive chemotherapy will be included.
Key exclusion criteria (5 listed)
- Contraindications to CMR (e.g.: patients with pacemakers, defibrillators or other implanted electronic devices).
- Life expectancy ≤ 12 months.
- Participating in another oncology clinical trial;
- Prior exposure to chemotherapy;
- History of active or prior cardiac disease (e.g., myocardial infarction, heart failure or base line left ventricular ejection fraction less than 55%).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Two dimensions speckle tracking and three dimension echocardiography and cardiac magnetic resonance imaging2D speckle tracking echo will be performed before chemotherapy and after mid-cycle and after completion of treatment. 3D echo and CMR will be performed before and after chemotherapy treatment. | Device | Cancer patients receiving chemotherapeutic drugs |
Primary outcome
Determine and compare the role of 2D speckle tracking vs. 3D echocardiography in assessment of early LV systolic dysfunction in patients receiving different chemotherapy combinations
Time frame: up to 6 months after starting chemotherapy
All patient will be undergo both 2D and 3D echocardiography before and after treatment to detect early LV systolic dysfunction.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2024.
Related trials for 2D Speckle Tracking Echocardiography
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Not yet recruitingObservational study
Measuring Heart Health in Both Term, Preterm and Unwell Newborn Babies With an Advanced Ultrasound Method: Speckle Tracking Echocardiography
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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.
John S Johny, MSC principal investigator
Assiut 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 2D Speckle Tracking Echocardiography and Breast Cancer, run by Assiut University at 1 site in Egypt.
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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 16 Jan 2024. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact John S Johny, MSC (01201045287, johnsafwatjohny91@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine and compare the role of 2D speckle tracking vs. 3D echocardiography in assessment of early LV systolic dysfunction in patients receiving different chemotherapy combinations (time frame: up to 6 months after starting chemotherapy). 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 16 Jan 2024.