Defining Robust Predictors of Chemotherapy Related Cardiotoxicity

September 19, 2023 updated by: University College, London
Observational prospective cohort study designed for patients with gastrointestinal cancers receiving a fluoropyrimidine based chemotherapy regimen.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  • Age >18
  • Consented to receive fluoropyrimidine chemotherapy for GI malignancies (gastro-oesophageal, colorectal, pancreatic)
  • Capacity to provide consent

Exclusion Criteria:

  • Age <18
  • Lacking capacity to consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months
Relationship of baseline cardiovascular risk with FIC
Time Frame: 12 months
Baseline cardiovascular risk assessed using QRISK3 cardiovascular risk calculator
12 months
Relationship of baseline cardiovascular risk with FIC
Time Frame: 12 months
Baseline cardiovascular risk assessed using SCORE2 cardiovascular risk calculator
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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)
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)
Using modified seattle angina questionnaire
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College, London

Collaborators

British Heart Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 13, 2021

Primary Completion (Estimated)

April 1, 2024

Study Completion (Estimated)

July 1, 2024

Study Registration Dates

First Submitted

December 1, 2021

First Submitted That Met QC Criteria

December 1, 2021

First Posted (Actual)

December 16, 2021

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 19, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 140342

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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