Status:
TERMINATED
Association of Ex Vivo Drug Response (EVDR) and Clinical Outcome in Ovarian Cancer
Lead Sponsor:
Exscientia AI Limited
Collaborating Sponsors:
AGO Research GmbH
Conditions:
Epithelial Ovarian Cancer
Eligibility:
FEMALE
18-125 years
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, ...
Eligibility Criteria
Inclusion
- 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
- 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%)
Key Trial Info
Start Date :
April 14 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 14 2024
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT06068738
Start Date
April 14 2023
End Date
August 14 2024
Last Update
September 26 2024
Active Locations (4)
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1
Barmherzige Schwestern Linz, Abteilung Gynäkologie und Geburtshilfe
Linz, Upper Austria, Austria, 4010
2
Med. Universität Wien - Universitätsklinik für Frauenheilkunde
Vienna, Austria, 1090
3
Evang. Kliniken Essen-Mitte gGmbH
Essen, North Rhine-Westphalia, Germany, 45136
4
Department für Frauengesundheit/Universitäts-Frauenklinik Tübingen
Tübingen, Germany, 72076