Left Ventricular DysfunctionCASPERNCT05939089
Cardiovascular Assessment of Pediatric Cancer Survivors
An observational study of Left Ventricular Dysfunction and Heart Failure, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this observational study is to evaluate cardiac and vascular health status of pediatric cancer survivors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Left Ventricular Dysfunction, Heart Failure
- What is being tested?
- ECG, Echocardiography, cTnI, NT-ProBNP
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2023to 22 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: All patients who are less than 18 years-old, diagnosed and treated for any type of cancer.
Who may be able to join
- Diagnosed cancer at pediatric age
Who cannot join
- Having cancer after 18 years of age
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: Cardiovascular Assessment of Pediatric Cancer Survivors: Understanding Long-Term Effects and Risks
The goal of this observational study is to evaluate cardiac and vascular health status of pediatric cancer survivors.
Read the detailed description
All pediatric cancer survivors were evaluated with cardiological examination, ECG, transthoracic echocardiography (transesophageal echocardiography when required), NT-proBNP, cTnI, kidney function tests, liver function tests, fasting blood glucose, cholesterol panel, iron, iron binding capacity, ferritin, transferrin saturation, B12, vitamin D, folic acid, urinanalysis, hemogram and a questionnaire about living with heart failure.
- Conditions
- Left Ventricular Dysfunction, Heart Failure
- Being tested
- ECG, Echocardiography, cTnI, NT-ProBNP
- Keywords
- Childhood Cancer Survivors, Cardiotoxicity, cancer treatment related heart diseases
- Medical subject headings
- Ventricular Dysfunction, Left, Heart Failure, Cardiotoxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECG, Echocardiography, cTnI, NT-ProBNPDiagnostic test
All pediatric cancer survivors are evaluated with cardiological examination, ECG, transthoracic echocardiography (transesophageal echocardiography when required), NT-proBNP, cTnI, kidney function tests, liver function tests, fasting blood glucose, cholesterol panel, iron, iron binding capacity, ferritin, transferrin saturation, B12, vitamin D, folic acid, urinanalysis, hemogram and a questionnaire about living with heart failure.
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of LV Dysfunction
Echocardiographic evaluation of left ventricular functions
Measured: From the first visit at cardio-oncology division through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start1 Jan 2023
- Primary completion15 Jun 2023
- Study completion22 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Left Ventricular DysfunctionStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 54 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, Faculty member
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05939089
- Sponsor's protocol ID
- COEXIST-2
- Acronym
- CASPER
- Status last verified
- Jul 2023
- First submitted
- 24 Jun 2023
- Last updated
- 11 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Sharing study data in a public place, requires additional (written) permission from all participants, and then from local IRB.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Assessment of Pediatric Cancer Survivors: Understanding Long-Term Effects and Risks
- ClinicalTrials.gov ID
- NCT05939089
- Acronym / sponsor ID
- CASPER / COEXIST-2
- Conditions
- Left Ventricular Dysfunction, Heart Failure
- Keywords
- Childhood Cancer Survivors, Cardiotoxicity, cancer treatment related heart diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 22 Jun 2023 (actual)
- First posted
- 11 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.
The goal of this observational study is to evaluate cardiac and vascular health status of pediatric cancer survivors.
Detailed description
All pediatric cancer survivors were evaluated with cardiological examination, ECG, transthoracic echocardiography (transesophageal echocardiography when required), NT-proBNP, cTnI, kidney function tests, liver function tests, fasting blood glucose, cholesterol panel, iron, iron binding capacity, ferritin, transferrin saturation, B12, vitamin D, folic acid, urinanalysis, hemogram and a questionnaire about living with heart failure.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who are less than 18 years-old, diagnosed and treated for any type of cancer.
Key inclusion criteria (1 listed)
- Diagnosed cancer at pediatric age
Key exclusion criteria (1 listed)
- Having cancer after 18 years of age
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 |
|---|---|---|
| ECG, Echocardiography, cTnI, NT-ProBNPAll pediatric cancer survivors are evaluated with cardiological examination, ECG, transthoracic echocardiography (transesophageal echocardiography when required), NT-proBNP, cTnI, kidney function tests, liver function tests, fasting blood glucose, cholesterol panel, iron, iron binding capacity, ferritin, transferrin saturation, B12, vitamin D, folic acid, urinanalysis, hemogram and a questionnaire about living with heart failure. | Diagnostic test | – |
Primary outcome
Rate of LV Dysfunction
Time frame: From the first visit at cardio-oncology division through study completion, an average of 2 years
Echocardiographic evaluation of left ventricular functions
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 11 Jul 2023.
- Individual participant dataSharing planned: Undecided. Sharing study data in a public place, requires additional (written) permission from all participants, and then from local IRB.
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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
Faculty member
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 Left Ventricular Dysfunction and Heart Failure, 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 1 inclusion and 1 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 11 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?
Rate of LV Dysfunction (time frame: From the first visit at cardio-oncology division through study completion, an average of 2 years). 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 11 Jul 2023.