CardiotoxicityNCT05298072
Identification of Novel Inflammation-related Biomarkers for Early Detection of Anthracycline-induced Cardiotoxicity in Breast Cancer Patients
An observational study of Cardiotoxicity and Breast Cancer, run by University Hospital, Essen.
Trial summary
This study aims to identify possible set of inflammatory biomarkers before, during and after anthracycline-based chemotherapy in breast cancer patients to identify (sub)clinical chemotherapy-related cardiac dysfunctionCRCD to identify patients who would benefit from additional cardioprotective therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiotoxicity, Breast Cancer, Heart Failure
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- Apr 2022to Dec 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
- Adult, Older adult
Study population: all patients presenting to cardio-oncology unit complying with eligibility criteria
Who may be able to join
- initial diagnosis of breast cancer
- planned Anthracycline-based therapy
- first-line chemotherapy
- first visit before initiation of chemotherapy
Who cannot join
- previous chemotherapy
- medical history of cardiac disease
- inflammation-modulating medication
- medication with RAS inhibitors
- pregnancy
- autoimmune disease
- drug addictions
- unwilling or unable to provide informed consent
About this study
This study aims to identify possible set of inflammatory biomarkers before, during and after anthracycline-based chemotherapy in breast cancer patients to identify (sub)clinical chemotherapy-related cardiac dysfunctionCRCD to identify patients who would benefit from additional cardioprotective therapy.
- Conditions
- Cardiotoxicity, Breast Cancer, Heart Failure
- Medical subject headings
- Cardiotoxicity, Breast Neoplasms, Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiotoxicity during observational period
Defined according to IC-OS 2021 Consensus Criteria
Measured: continuous evaluation during observational period of 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2022
- Study startApr 2022 (estimated)
- Primary completionApr 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CardiotoxicityStudies 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
- Cohort
- Time perspective
- Other
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Essen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05298072
- Sponsor's protocol ID
- 22-10590-BO
- Status last verified
- Mar 2022
- First submitted
- 17 Mar 2022
- Last updated
- 28 Mar 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 28 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Novel Inflammation-related Biomarkers for Early Detection of Anthracycline-induced Cardiotoxicity in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT05298072
- Acronym / sponsor ID
- 22-10590-BO
- Conditions
- Cardiotoxicity, Breast Cancer, Heart Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University Hospital, EssenUniversity, hospital or other
- Study start
- Apr 2022 (estimated)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 28 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.
This study aims to identify possible set of inflammatory biomarkers before, during and after anthracycline-based chemotherapy in breast cancer patients to identify (sub)clinical chemotherapy-related cardiac dysfunctionCRCD to identify patients who would benefit from additional cardioprotective therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- all patients presenting to cardio-oncology unit complying with eligibility criteria
Key inclusion criteria (4 listed)
- initial diagnosis of breast cancer
- planned Anthracycline-based therapy
- first-line chemotherapy
- first visit before initiation of chemotherapy
Key exclusion criteria (8 listed)
- previous chemotherapy
- medical history of cardiac disease
- inflammation-modulating medication
- medication with RAS inhibitors
- pregnancy
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
Cardiotoxicity during observational period
Time frame: continuous evaluation during observational period of 12 months
Defined according to IC-OS 2021 Consensus Criteria
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiotoxicity and Breast Cancer, run by University Hospital, Essen.
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 8 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 28 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Cardiotoxicity during observational period (time frame: continuous evaluation during observational period of 12 months). 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 28 Mar 2022.