Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study is multicenter, post-authorization, observational and ambispective
Cardiovascular toxicity produced by antitumoral drugs has a considerable impact in life wellness and prognosis of cancer patients, which can imply the suspension of the desired antitumoral treatment or even risk the patient´s life. The development of a risk score for these patients, as well as specific methodology for early detection of cardiotoxicity would therefore be a great outcome to trigger new strategies for the monitoring of these patients. Currently there is a lack of a clinical score to predict cardiotoxicity risk. Therefore, there is an urgent need to identify new myocardial injury biomarkers and novel imaging parameters for measuring ventricular function that would increase the sensitivity of the traditional methods used for the early detection of cardiotoxicity.
The objectives of the present study are the following:
The study is a multicenter one, observational and ambispective. We will include all the patients assessed by the Oncology and Haematology Departments in each participant hospital that are about to initiate or are undergoing chemotherapy with any of the drugs specified in the study protocol. Patients will be monitorized during the treatment, undergoing an echocardiography study and a blood sample collection in each clinical timepoint. All these parameters will hopefully shed some light for the development of a clinical risk score as well as identifying new early biomarkers for cardiotoxicity.
The initial follow-up in this phase of the study will be 2 years
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient under study condition | Patient under study condition |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Change in CARDIOTOXICITY DEVELOPMENT RISK SCORE | Risk of cardiovascular toxicity by antitumoral agents is multifactorial.
| 21 days, 3 months, 6 months, 1 year, 1.5 years and 2 years |
| change in EARLY DETECTION OF CARDIOTOXICITY | Early recognition of cardiotoxicity can help determine whether to continue treatment with a particular type of drug and set up preventive treatments.
| 21 days, 3 months, 6 months, 1 year, 1.5 years and 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of cardiovascular toxicity in its different forms | Cardiotoxicity severity:
| 2 years |
| Incidence of cardiovascular toxicity in relation to the cumulative dose |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
A case is defined as a patient on treatment (started or programmed, regardless of previous treatments or prior radiotherapy) with the following target antineoplastic agents:
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| José Luis López-Sendón | Contact | +34 639148765 | jlopezsendon@gmail.com | |
| Maria Torrente | Contact | (+34) 607684323 | maria.torrente@idipaz.es |
| Name | Affiliation | Role |
|---|---|---|
| Jose Luis Lopez-Sendon | La Paz University Hospital- Chief of Cardiology Department | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| La pAz University Hospital | Recruiting | Madrid | Madrid | 28046 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33624069 | Derived | Caro-Codon J, Lopez-Fernandez T, Alvarez-Ortega C, Zamora Aunon P, Rodriguez IR, Gomez Prieto P, Buno Soto A, Canales Albendea M, Albaladejo A, Mediavilla G, Feliu Batlle J, Rodriguez Fraga O, Martinez Monzonis A, Gonzalez-Costello J, Serrano Antolin JM, Cadenas Chamorro R, Gonzalez-Juanatey JR, Lopez-Sendon J; CARDIOTOX registry investigators. Cardiovascular risk factors during cancer treatment. Prevalence and prognostic relevance: insights from the CARDIOTOX registry. Eur J Prev Cardiol. 2022 May 6;29(6):859-868. doi: 10.1093/eurjpc/zwaa034. |
| Label | URL |
|---|---|
| Web site of the study | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
whole blood
|
| 21 days, 3 months, 6 months, 1 year, 1.5 years and 2 years |
| •Incidence of cardiovascular toxicity in relation to the kind of antitumor agent |
| 21 days, 3 months, 6 months, 1 year, 1.5 years and 2 years |
| •Analyze the sensitivity and specificity of EKG changes regarding new changes in biomarkers, clinical and echocardiographic parameters | - EKG | 21 days, 3 months, 6 months, 1 year, 1.5 years and 2 years |
| Analyze whether alterations of biological markers predate clinical, echocardiographic and functional parameters |
| 21 days, 3 months, 6 months, 1 year, 1.5 years and 2 years |
| Compare the effectiveness of early identification of cardiovascular toxicity of high-sensitivity troponin (troponin T) compared to a conventional troponin |
| 21 days, 3 months, 6 months, 1 year, 1.5 years and 2 years |
| Define the sensitivity and specificity of the left ventricle ejection fraction in the detection of cardiovascular toxicity |
| 21 days, 3 months, 6 months, 1 year, 1.5 years and 2 years |
| • Define the sensitivity and specificity of new ventricular function parameters in cardiovascular toxicity screening. | - Longitudinal global strain | 21 days, 3 months, 6 months, 1 year, 1.5 years and 2 years |
| Economic analysis derived from the diagnostic strategy with biomarkers versus echocardiography. | Economic analysis comparing efficacy of biomarkers versus echocardiography | 2 years |