Development of a Pharmacogenomic Panel for Early Detection of Chemotherapy- and Immunotherapy-Induced Cardiotoxicity.

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBeneficência Portuguesa de São Paulo

About this trial

To evaluate the use of a pharmacogenetic and pharmacoepigenetic panel for predicting chemotherapy- and immunotherapy-induced cardiotoxicity in cancer patients.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with a confirmed diagnosis of breast cancer who are scheduled to initiate treatment with anthracyclines and/or HER2-targeted therapies (anti-HER2 therapies).

Disqualifiers

Patients with a left ventricular ejection fraction (LVEF) < 50%;

Patients who have undergone chemotherapy and/or radiotherapy within the previous year;

Patients with chronic kidney disease and a glomerular filtration rate (GFR) < 30 mL/min/1.73 m²;

Patients with uncontrolled hypertension;

Trial population

A prospective cohort of adult breast cancer patients receiving cardiotoxic cancer therapies, followed for cardiovascular assessment and multi-omics profiling to identify predictors of treatment-related cardiotoxicity.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

1,000 Participants
are grouped into 4 trial groups
Group A: Discovery cohort with cardiotoxicity
Group B: Validation cohort with cardiotoxicity
Group C: Discovery cohort without cardiotoxicity
Group D: Validation cohort without cardiotoxicity

Trial outcomes

Primary outcomes

1

Cardiotoxicity

Throughout treatment and follow-up, cardiotoxicity will be defined according to the criteria established by the 2022 European Society of Cardiology (ESC) Cardio-Oncology Guidelines.

Time frame
1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.