Early detection and prediction of cardiotoxicity in breast cancer patients treated with chemotherapy using the high sensitivity troponin T assay.

Early detection and prediction of cardiotoxicity in breast cancer patients treated with chemotherapy using the high sensitivity troponin T assay. - Use of high sensitivity troponin t to detect and predict cardiotoxicity

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON37774

Enrollment

Registered

2012-09-18

Start date

2013-01-11

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cardiotoxicity heart failure

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: -Female breast cancer patients -Age between 30-60 years -18-weeks of chemotherapy-treatment, adjuvant or neo-adjuvant -Chemotherapy may include: (AC) adriamycin/cyclophosphamide, (FEC) fluorouracil/epiribicin/cyclophosphamide, (TAC) taxotere/ adriamycin/cyclophosphamide -Ejection fraction > 50%

Exclusion criteria

Exclusion criteria: -Ejection fraction

Design outcomes

Primary

Measure	Time frame
Relation between hs-TNT values and cardiac dysfunction (measured by left ventricular ejection fraction with echocardiography) after chemotherapy.	—

Secondary

Measure	Time frame
Secondary objectives of this study are to investigate the relation between the change in hs-TNT values and cardiac function after Ctx. 1. hs-TNT kinetics during Ctx and relation to cardiac function (% LVEF). (delta change within one Ctx cycle, delta change between Ctx cycles, delta change baseline and final hs-TNT value) 2. Detection and prediction of cardiotoxicity (definition: an asymptomatic reduction >10% of the LVEF reaching ,5% of the LVEF reaching	—

Measure

Time frame

Secondary objectives of this study are to investigate the relation between the change in hs-TNT values and cardiac function after Ctx. 1. hs-TNT kinetics during Ctx and relation to cardiac function (% LVEF). (delta change within one Ctx cycle, delta change between Ctx cycles, delta change baseline and final hs-TNT value) 2. Detection and prediction of cardiotoxicity (definition: an asymptomatic reduction >10% of the LVEF reaching ,5% of the LVEF reaching

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Countries

Netherlands

Outcome results