CardiotoxicityEARLY-CATCHNCT04046315
Early Detection of Cardiac Damage With CMR in Women With Breast Cancer
An observational study of Cardiotoxicity and Breast Cancer, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
With this study the investigators will assess early cardiac damage by means of Global Longitudinal Strain (GLS) in newly diagnosed breast cancer (BC) patients treated with anthracycline-based chemotherapy, and to investigate whether myocardial damage as measured with T1 / T2 Cardiovascular Magnetic Resonance (CMR)… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cardiotoxicity, Breast Cancer, Chemotherapy Induced Systolic Dysfunction
- What is being tested?
- CMR
- How many people
- 55 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Mar 2020to 31 Mar 2021
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The study population will be recruited from the general BC population receiving (neo-) adjuvant chemotherapy. Patients with a new diagnosis of malignant neoplasm of the breast, codes C50.0-C50.9, according to the World Health Organization International Classification of Diseases (WHO-ICD) will be eligible for participation.
Who may be able to join
- Female
- Age ≥ 18 years
- A diagnosis of primary breast cancer
- Starting (neo-) adjuvant chemotherapy treatment within 2 months after screening
- Cardiotoxicity risk score of intermediate, high or very high risk
Who cannot join
- Previous radiotherapy or systemic cancer treatment
- Cancer metastasis
- Life expectancy of less than 6 months
- History of myocardial infarction or heart failure
- Known contra-indications for CMR
- Refusal or inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Radboud University Medical Center
Nijmegen, 6500 HB
Yvonne Koop, MSc
About this study
With this study the investigators will assess early cardiac damage by means of Global Longitudinal Strain (GLS) in newly diagnosed breast cancer (BC) patients treated with anthracycline-based chemotherapy, and to investigate whether myocardial damage as measured with T1 / T2 Cardiovascular Magnetic Resonance (CMR) mapping and plasma hs-Troponin T is related to changes in GLS.
- Being tested
- CMR
- Medical subject headings
- Cardiotoxicity, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CMRDiagnostic test
GLS measurement with CMR
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Longitudinal Strain (GLS) change after chemotherapy compared to baseline
A relative reduction in Global Longitudinal Strain (GLS) assessed with CMR
Measured: Baseline and 2 weeks after the last chemotherapy cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2019
- Study start1 Mar 2020
- Primary completion31 Mar 2021 (estimated)
- Study completion31 Mar 2021 (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.
- More trials run by Radboud University Medical CenterThe 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
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Saloua El Messaoudi, PhD, Study chair, Radboud University Medical CenterAngela Maas, PhD, Principal investigator, Radboud University Medical CenterRobin Nijveldt, PhD, Study chair, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04046315
- Sponsor's protocol ID
- 108818
- Acronym
- EARLY-CATCH
- Status last verified
- Aug 2019
- First submitted
- 1 Aug 2019
- Last updated
- 16 Mar 2020
- 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 16 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection of Cardiac Damage With CMR in Women With Breast Cancer
- ClinicalTrials.gov ID
- NCT04046315
- Acronym / sponsor ID
- EARLY-CATCH / 108818
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 31 Mar 2021 (estimated)
- Study completion
- 31 Mar 2021 (estimated)
- First posted
- 6 Aug 2019 (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.
With this study the investigators will assess early cardiac damage by means of Global Longitudinal Strain (GLS) in newly diagnosed breast cancer (BC) patients treated with anthracycline-based chemotherapy, and to investigate whether myocardial damage as measured with T1 / T2 Cardiovascular Magnetic Resonance (CMR) mapping and plasma hs-Troponin T is related to changes in GLS.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be recruited from the general BC population receiving (neo-) adjuvant chemotherapy. Patients with a new diagnosis of malignant neoplasm of the breast, codes C50.0-C50.9, according to the World Health Organization International Classification of Diseases (WHO-ICD) will be eligible for participation.
Key inclusion criteria (5 listed)
- Female
- Age ≥ 18 years
- A diagnosis of primary breast cancer
- Starting (neo-) adjuvant chemotherapy treatment within 2 months after screening
- Cardiotoxicity risk score of intermediate, high or very high risk
Key exclusion criteria (6 listed)
- Previous radiotherapy or systemic cancer treatment
- Cancer metastasis
- Life expectancy of less than 6 months
- History of myocardial infarction or heart failure
- Known contra-indications for CMR
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 |
|---|---|---|
| CMRGLS measurement with CMR | Diagnostic test | – |
Primary outcome
Global Longitudinal Strain (GLS) change after chemotherapy compared to baseline
Time frame: Baseline and 2 weeks after the last chemotherapy cycle
A relative reduction in Global Longitudinal Strain (GLS) assessed with CMR
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2020.
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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.
Saloua El Messaoudi, PhD study chair
Radboud University Medical Center
Angela Maas, PhD principal investigator
Radboud University Medical Center
Robin Nijveldt, PhD study chair
Radboud University Medical Center
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 Cardiotoxicity and Breast Cancer, run by Radboud University Medical Center at 1 site in Netherlands.
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 5 inclusion and 6 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 Mar 2020. 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 Netherlands. 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 Yvonne Koop, MSc (+31 24-3616785, Yvonne.Koop@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global Longitudinal Strain (GLS) change after chemotherapy compared to baseline (time frame: Baseline and 2 weeks after the last chemotherapy cycle). 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 Mar 2020.