EXCYTE-1 is a multicentre, prospective observational study to investigate the relationship between ex vivo drug response (EVDR), measured in ovarian tumour-derived samples using high content imaging, and actual patient clinical response. Patients with newly diagnosed or relapsed/refractory epithelial ovarian carcinoma, that present with malignant effusions (ascites or pleural effusions), will be enrolled in the study before starting their initial or next treatment line. Enrolled patients will be asked to provide ascites, peripheral blood and fresh tumour tissue if available. Samples will be shipped to the sponsor laboratory and their response to standard of care drugs evaluated ex vivo. Participants will: * provide samples during routine clinical procedures * agree that data about their medical history, diagnosis and health status at the following timepoints are collected: at signature of the consent form, at the time samples are provided, at start of the therapy, upon completion of the therapy, regularly after completion of the therapy
Study Type
OBSERVATIONAL
Enrollment
13
Collection of ascites, blood and fresh tumour tissues (if available)
Barmherzige Schwestern Linz, Abteilung Gynäkologie und Geburtshilfe
Linz, Upper Austria, Austria
Med. Universität Wien - Universitätsklinik für Frauenheilkunde
Vienna, Austria
Evang. Kliniken Essen-Mitte gGmbH
Essen, North Rhine-Westphalia, Germany
Department für Frauengesundheit/Universitäts-Frauenklinik Tübingen
Tübingen, Germany
Association between ex vivo drug response (EVDR) of ascites samples and clinical outcome
EVDR will be compared to the clinical outcome, determined based on local practice
Time frame: From time of diagnosis (sampling) until disease progression or End of Study (EoS), whichever comes first, assessed up to 45 month.
Technical success rate
Percentage of ascites samples meeting inclusion and exclusion criteria that meet the quality criteria as per Exscientia SOPs (Standard Operating Procedures).
Time frame: From study start to study end (up to 45 month).
Prognostic value of EVDR of ascites samples in PFS (Progression-free survival) prediction
False positive and false negative rate in PFS prediction at 6 and 12 month
Time frame: From diagnosis until month 6 (12) or relapse/ EoS, whatever comes first.
Biomarker impact on EVDR and its prognostic value
Hazard rate associated with established biomarkers and interaction between these markers and EVDR outcome
Time frame: From study start to study end (up to 45 month).
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