CardiotoxicityNCT05159479
Defining Robust Predictors of Chemotherapy Related Cardiotoxicity
An observational study of Cardiotoxicity and Gastrointestinal Neoplasms, run by University College, London at 1 site in United Kingdom.
Trial summary
Observational prospective cohort study designed for patients with gastrointestinal cancers receiving a fluoropyrimidine based chemotherapy regimen. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiotoxicity, Gastrointestinal Neoplasms
- How many people
- 600 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Oct 2021to 1 Jul 2024
- 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: Participants will be recruited from secondary or tertiary care centres from oncology clinics. Participants included will be undergoing chemotherapy in the neoadjuvant, adjuvant and palliative setting.
Who may be able to join
- Age >18
- Consented to receive fluoropyrimidine chemotherapy for GI malignancies (gastro-oesophageal, colorectal, pancreatic)
- Capacity to provide consent
Who cannot join
- Age <18
- Lacking capacity to consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
St Bartholomews Hospital
London, EC1A 7BE
Aderonke Abiodun, aderonketemilade.abiodun@nhs.net
charlotte.manisty@nhs.net
About this study
Observational prospective cohort study designed for patients with gastrointestinal cancers receiving a fluoropyrimidine based chemotherapy regimen.
Read the detailed description
All enrolled participants will undergo baseline cardiovascular risk assessment (using QRISK3 and SCORE 2 risk calculators), cardiac, oncological and medication history. All participants will have serial cardiac symptom assessment, 12 lead ECG and cardiac biomarker assessments(high sensitivity troponin T and NT pro BNP) at baseline, on completion of the first cycle of treatment and post completion of treatment. Participants will be followed up for the development of cardiotoxicity.
- Conditions
- Cardiotoxicity, Gastrointestinal Neoplasms
- Keywords
- Fluoropyrimidine, Cardiotoxicity, Cardio-oncology
- Medical subject headings
- Cardiotoxicity, Gastrointestinal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of fluoropyrimidine induced cardiotoxicity (FIC)
Fluoropyrimidine induced cardiotoxicity defined as a composite of:
- Types 1-3 myocardial infarction with troponin >99th percentile upper limit,
- Incident myocardial ischaemia (chest pain with or without new inducible perfusion abnormality on perfusion cardiac MRI,
- Myocarditis (diagnosed as per European Society of Cardiology Consensus statement)
- Incident heart failure (HF) diagnosis (symptoms with raised N-terminal pro-B-type natriuretic peptide (NTproBNP )> 400pg/ml or HF hospitalisation),
- Incident arrhythmia (excluding isolated ectopy) or sudden cardiac death.
Measured: 12 months
Relationship of baseline cardiovascular risk with FIC
Baseline cardiovascular risk assessed using QRISK3 cardiovascular risk calculator
Measured: 12 months
Relationship of baseline cardiovascular risk with FIC
Baseline cardiovascular risk assessed using SCORE2 cardiovascular risk calculator
Measured: 12 months
Secondary outcomes (3)
Change in cardiac biomarkers (high sensitivity troponin T)
Measured: Assessed at baseline pre chemotherapy, after cycle 1 chemotherapy (46 hours for patients on 5-FU and day 14 for patients on capecitabine) and at end of treatment (at 6 weeks post completion)
Change in cardiac biomarkers (NT pro BNP)
Measured: Assessed at baseline pre chemotherapy, after cycle 1 chemotherapy (46 hours for patients on 5-FU and day 14 for patients on capecitabine) and at end of treatment (at 6 weeks post completion)
Cardiovascular symptom assessment
Using modified seattle angina questionnaire
Measured: Assessed at baseline pre chemotherapy, after cycle 1 chemotherapy (46 hours for patients on 5-FU and day 14 for patients on capecitabine) and at end of treatment (at 6 weeks post completion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2021
- Study start13 Oct 2021
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Jul 2024 (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 University College, LondonThe 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
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- British Heart Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05159479
- Sponsor's protocol ID
- 140342
- Status last verified
- Sep 2023
- First submitted
- 1 Dec 2021
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining Robust Predictors of Chemotherapy Related Cardiotoxicity
- ClinicalTrials.gov ID
- NCT05159479
- Acronym / sponsor ID
- 140342
- Conditions
- Cardiotoxicity, Gastrointestinal Neoplasms
- Keywords
- Fluoropyrimidine, Cardiotoxicity, Cardio-oncology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- British Heart Foundation
- Study start
- 13 Oct 2021 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 16 Dec 2021 (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.
Observational prospective cohort study designed for patients with gastrointestinal cancers receiving a fluoropyrimidine based chemotherapy regimen.
Detailed description
All enrolled participants will undergo baseline cardiovascular risk assessment (using QRISK3 and SCORE 2 risk calculators), cardiac, oncological and medication history. All participants will have serial cardiac symptom assessment, 12 lead ECG and cardiac biomarker assessments(high sensitivity troponin T and NT pro BNP) at baseline, on completion of the first cycle of treatment and post completion of treatment. Participants will be followed up for the development of cardiotoxicity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited from secondary or tertiary care centres from oncology clinics. Participants included will be undergoing chemotherapy in the neoadjuvant, adjuvant and palliative setting.
Key inclusion criteria (3 listed)
- Age >18
- Consented to receive fluoropyrimidine chemotherapy for GI malignancies (gastro-oesophageal, colorectal, pancreatic)
- Capacity to provide consent
Key exclusion criteria (2 listed)
- Age <18
- Lacking capacity to consent
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 fluoropyrimidine induced cardiotoxicity (FIC)
Time frame: 12 months
Fluoropyrimidine induced cardiotoxicity defined as a composite of: * Types 1-3 myocardial infarction with troponin >99th percentile upper limit, * Incident myocardial ischaemia (chest pain with or without new inducible perfusion abnormality on perfusion cardiac MRI, * Myocarditis (diagnosed as per European Society of Cardiology Consensus statement) * Incident heart failure (HF) diagnosis (symptoms with raised N-terminal pro-B-type natriuretic peptide (NTproBNP )> 400pg/ml or HF hospitalisation), * Incident arrhythmia (excluding isolated ectopy) or sudden cardiac death.
Relationship of baseline cardiovascular risk with FIC
Time frame: 12 months
Baseline cardiovascular risk assessed using QRISK3 cardiovascular risk calculator
Relationship of baseline cardiovascular risk with FIC
Time frame: 12 months
Baseline cardiovascular risk assessed using SCORE2 cardiovascular risk calculator
3 secondary outcomes
Change in cardiac biomarkers (high sensitivity troponin T)
Time frame: Assessed at baseline pre chemotherapy, after cycle 1 chemotherapy (46 hours for patients on 5-FU and day 14 for patients on capecitabine) and at end of treatment (at 6 weeks post completion)
Change in cardiac biomarkers (NT pro BNP)
Time frame: Assessed at baseline pre chemotherapy, after cycle 1 chemotherapy (46 hours for patients on 5-FU and day 14 for patients on capecitabine) and at end of treatment (at 6 weeks post completion)
Cardiovascular symptom assessment
Time frame: Assessed at baseline pre chemotherapy, after cycle 1 chemotherapy (46 hours for patients on 5-FU and day 14 for patients on capecitabine) and at end of treatment (at 6 weeks post completion)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Individual participant dataSharing planned: No
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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.
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 Gastrointestinal Neoplasms, run by University College, London at 1 site in United Kingdom.
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 3 inclusion and 2 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 21 Sep 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 United Kingdom. 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 Aderonke Abiodun (07737138851, aderonketemilade.abiodun@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of fluoropyrimidine induced cardiotoxicity (FIC) (time frame: 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 21 Sep 2023.