Trials / Unknown
UnknownNCT02665312
Cardiotoxicity and Risk Factors in Patients With Colorectal Cancer Receiving Fluoropyrimidine
CHEmotherapy-induced Cardiotoxicity and Study of risK Factor Correlation in Patients With Colorectal Cancer Receiving Oral or INfusional Fluoropyrimidine Treatment - CHECKPOINT
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 200 (estimated)
- Sponsor
- Fondazione del Piemonte per l'Oncologia · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
observational prospective study, designed for patients with colorectal cancer receiving for the first time 5-FU or capecitabine, with or without other chemotherapy combinations.
Detailed description
All patients enrolled will be evaluated for cardiovascular risk factors and, if resulted at cardiovascular risk, they will be submitted to cardiac examination and therapy optimization before starting chemotherapy. Patients will be evaluated with 12-lead ECG and blood sample for TnI and NT pro-BNP before start chemotherapy and on day 3 of chemotherapy during the first, second and third cycle. All patients developing cardiovascular events will be submitted to blood sample for TnI, NT-proBNP, hsTnI and cardiac examination.
Conditions
Timeline
- Start date
- 2016-01-01
- Primary completion
- 2018-01-01
- Completion
- 2019-01-01
- First posted
- 2016-01-27
- Last updated
- 2016-09-23
Locations
8 sites across 1 country: Italy
Source: ClinicalTrials.gov record NCT02665312. Inclusion in this directory is not an endorsement.