Defining Robust Predictors of Chemotherapy Related Cardiotoxicity

Recruiting

• Conditions: Gastrointestinal Neoplasms; Cardiotoxicity

• Registration Number: NCT05159479
• Lead Sponsor: University College, London

Brief Summary

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 Timeline

• Study Start: 2021-10-13
• Study First Submitted: 2021-12-01
• Study First Submitted QC: 2021-12-01
• Study First Posted: 2021-12-16
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-19
• Last Update Posted: 2023-09-21
• Primary Completion: 2024-04-01
• Study Completion: 2024-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of fluoropyrimidine induced cardiotoxicity (FIC)	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	12 months	Baseline cardiovascular risk assessed using SCORE2 cardiovascular risk calculator

Secondary Outcome Measures

Name	Time	Method
Change in cardiac biomarkers (high sensitivity troponin T)	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)	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	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

Trial Locations

Locations (1)

St Bartholomews Hospital; 🇬🇧 London, United Kingdom