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| Name | Class |
|---|---|
| British Heart Foundation | OTHER |
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Observational prospective cohort study designed for patients with gastrointestinal cancers receiving a fluoropyrimidine based chemotherapy regimen.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of fluoropyrimidine induced cardiotoxicity (FIC) | Fluoropyrimidine induced cardiotoxicity defined as a composite of:
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aderonke Abiodun | Contact | 07737138851 | aderonketemilade.abiodun@nhs.net |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Bartholomews Hospital | Recruiting | London | EC1A 7BE | United Kingdom |
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| ID | Term |
|---|---|
| D066126 | Cardiotoxicity |
| D005770 | Gastrointestinal Neoplasms |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 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 | 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) |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
| D011832 | Radiation Injuries |
| D014947 | Wounds and Injuries |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |