Association of Ex Vivo Drug Response (EVDR) and Clinical Outcome in Ovarian Cancer

Recruiting

• Conditions: Epithelial Ovarian Cancer
• Interventions: Other: Biological sample collection

• Registration Number: NCT06068738
• Lead Sponsor: Exscientia GmbH

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-14
• Study First Submitted: 2023-09-22
• Study First Submitted QC: 2023-09-28
• Study First Posted: 2023-10-05
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-08
• Last Update Posted: 2024-01-09
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• Minimum age 18 years
• Signed informed consent form
• Confirmed diagnosis of ovarian cancer except low grade serous, clear cell and mucinous histology
• Where patients are treatment naïve, patients need to have disease stage FIGO (International Federation of Gynecology and Obstetrics) III or FIGO IV.
• Patient is expected to receive primary chemotherapy/maintenance after initial surgical debulking or a further line of systemic therapy in the relapsed setting according to treatment guidelines
• Feasibility of collecting malignant ascites and/or pleural effusion during either primary debulking surgery or a routine drainage procedure prior to initiation of the first or next line of systemic therapy
• ECOG (Eastern Cooperative Oncology Group) stage 0-2

Exclusion Criteria

• Previously study participation
• Known or suspected HIV or active Hepatitis B and/or C infection or active COVID-19 infection
• Anticancer treatment or radiation therapy of the region which is to be drained or biopsied within the last 4 weeks
• Patient unfit or not willing to receive any further systemic treatment
• Patient is treated with therapeutics not tested in the assay - with the exception of anti-VEGF (Vascular endothelial growth factor) therapy
• Known pregnancy
• Sample quality criteria are not met (at least 250ml of ascites available, no signes of bacterial superinfection, no additives, at least 1% EpCAM (Epithelial Cell Adhesion Molecule) positive cells, viability at least 60%)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Relapsed/refractory	Biological sample collection	Relapsed/refractory (r/r) ovarian carcinoma patients presenting with ascites before start of their next therapy line (for r/r patients).
Newly diagnosed	Biological sample collection	Newly diagnosed ovarian carcinoma patients presenting with ascites and/or pleural effusions before start of their initial therapy.

Primary Outcome Measures

Name	Time	Method
Association between ex vivo drug response (EVDR) of ascites samples and clinical outcome	From time of diagnosis (sampling) until disease progression or End of Study (EoS), whichever comes first, assessed up to 45 month.	EVDR will be compared to the clinical outcome, determined based on local practice

Secondary Outcome Measures

Name	Time	Method
Prognostic value of EVDR of ascites samples in PFS (Progression-free survival) prediction	From diagnosis until month 6 (12) or relapse/ EoS, whatever comes first.	False positive and false negative rate in PFS prediction at 6 and 12 month
Biomarker impact on EVDR and its prognostic value	From study start to study end (up to 45 month).	Hazard rate associated with established biomarkers and interaction between these markers and EVDR outcome
Technical success rate	From study start to study end (up to 45 month).	Percentage of ascites samples meeting inclusion and exclusion criteria that meet the quality criteria as per Exscientia SOPs (Standard Operating Procedures).

Trial Locations

Locations (4)

Department für Frauengesundheit/Universitäts-Frauenklinik Tübingen; 🇩🇪 Tübingen, Germany

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