Defining Robust Predictors of Chemotherapy Related Cardiotoxicity

NCT05159479 | Unknown

• 1 other identifier: 140342
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

Observational prospective cohort study designed for patients with gastrointestinal cancers receiving a fluoropyrimidine based chemotherapy regimen.

Conditions

Cardiotoxicity; Gastrointestinal Neoplasms

Keywords

Fluoropyrimidine; Cardiotoxicity; Cardio-oncology

Outcome Measures

Primary Outcomes (3)

• 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.

  12 months

• Relationship of baseline cardiovascular risk with FIC

  Baseline cardiovascular risk assessed using QRISK3 cardiovascular risk calculator

  12 months

• Relationship of baseline cardiovascular risk with FIC

  Baseline cardiovascular risk assessed using SCORE2 cardiovascular risk calculator

  12 months

Secondary Outcomes (3)

• 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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Age \<18
• Lacking capacity to consent

Sponsors & Collaborators

• University College, London: lead
• British Heart Foundation: collaborator

Study Sites (1)

St Bartholomews Hospital

London, EC1A 7BE, United Kingdom

RECRUITING

MeSH Terms

Conditions

Cardiotoxicity; Gastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Central Study Contacts

Aderonke Abiodun

CONTACT

07737138851; aderonketemilade.abiodun@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2021
• First Posted: December 16, 2021
• Study Start: October 13, 2021
• Primary Completion: April 1, 2024
• Study Completion: July 1, 2024
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)