Improving prediction of response to neoadjuvant treatment in patients with breast cancer by combining liquid biopsies with multiparametric MRI: protocol of the LIMA study - a multicentre prospective observational cohort study

通过将液体活检与多参数 MRI 相结合来改善对乳腺癌患者新辅助治疗反应的预测:LIMA 研究方案 - 一项多中心前瞻性观察队列研究

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作者:Liselore M Janssen, Britt B M Suelmann, Sjoerd G Elias, Markus H A Janse, Paul J van Diest, Elsken van der Wall, Kenneth G A Gilhuijs

Aim

To combine multiparametric MRI and liquid biopsies in patients with breast cancer to predict residual cancer burden (RCB) after NAC, in adjunct to standard clinico-pathological information. Predictions will be made before the start of NAC, approximately halfway during treatment and after completion of NAC.

Methods

In this multicentre prospective observational study we aim to enrol 100 patients. Multiparametric MRI will be performed prior to NAC, approximately halfway and after completion of NAC. Liquid biopsies will be obtained immediately prior to every cycle of chemotherapy and after completion of NAC. The primary endpoint is RCB in the surgical resection specimen following NAC. Collected data will primarily be analysed using multivariable techniques such as penalised regression techniques. Ethics and dissemination: Medical Research Ethics Committee Utrecht has approved this study (NL67308.041.19). Informed consent will be obtained from each participant. All data are anonymised before publication. The findings of this study will be submitted to international peer-reviewed journals.

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