Association of Ex Vivo Drug Response (EVDR) and Clinical Outcome in Ovarian Cancer (EXCYTE-1)

Exscientia

Status

Terminated

Conditions

Epithelial Ovarian Cancer

Treatments

Other: Biological sample collection

Study type

Observational

Funder types

Industry

Identifiers

NCT06068738

AC2202

Details and patient eligibility

About

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

Enrollment

13 patients

Sex

Female

Ages

18 to 125 years old

Volunteers

No Healthy Volunteers

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%)