Observational longitudinal cohort to investigate the incidence of cancer treatment-related cardiovascular toxicity, identification of risk factors and evaluation of treatment strategies.
ID
Bron
Verkorte titel
Aandoening
Patients who will be-, are-, or have been treated with potential cardiotoxic oncological treatment and therefore a referred to specialized cardio-oncology units.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Cardiovascular toxicity
Achtergrond van het onderzoek
Rationale: The attention for cardiovascular side effects of anticancer treatment has grown and led to increased knowledge of pathophysiological mechanisms, diagnostics- and treatment of these feared side effects. Despite these advantages, there are still several unresolved issues and challenges within the field of cardio-oncology such as absence of a validated risk stratification model and optimal treatment for cancer therapy-related cardiac dysfunction. ONCOR is a prospective multicenter registry in which clinical information of patients visiting cardio-oncology units across the Netherlands will be collected. The primary objective is to register the incidence of cardiovascular toxicity of cancer treatment. Secondary objectives include the influence of cardiovascular toxicity on oncological treatment, identification of risk factors for cardiotoxicity. Additionally, the registry provides a platform for future (interventional) studies, including registry-based randomized clinical trials.
Objective: Incidence of cardiovascular toxicity of cancer treatment; Identification of risk factors for the development of cardiovascular toxicity.
Study design: Prospective multicenter observational cohort study
Study population: Patients receiving cardio-oncological care in Dutch hospitals.
Intervention: No intervention will take place. Patients are treated according to routine clinical practice.
Main study parameters/endpoints: The occurrence of cardiovascular toxicity and impact on oncological treatment. Identifying risk factors for development of cardiovascular toxicity.
Determinants: Registration of oncological treatment and the occurrence of cardiovascular side effects.
Nature and extent of the burden and risk associated with participation, benefit and group relatedness: Participation in the registry will not give extra burden or risk for the patients. It will not provide direct benefit for the patient.
Doel van het onderzoek
Observational longitudinal cohort to investigate the incidence of cancer treatment-related cardiovascular toxicity, identification of risk factors and evaluation of treatment strategies.
Onderzoeksopzet
Visits at the cardio-oncology unit will be registered.
Onderzoeksproduct en/of interventie
No intervention will take place. Patients are treated according to routine clinical practice.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- Patients who visit a specialized cardio-oncology unit.
- Age ≥18 years.
- Willing and able to provide written informed consent for participation
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- Conditions that affect a patient’s ability to provide written informed consent, such as psychiatric or mental disorders, language barriers or other factors
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL8064 |
| Ander register | METC UMCU : METC 18/639 |