Association of Ex Vivo Drug Response (EVDR) and Clinical Outcome in Ovarian Cancer
Key facts
- Who runs it
- Exscientia AI Limited
- Where
- Austria and Germany4 sites in 2 countriesChoose a country to see its sites
- Trial code
- Status
- Terminated
- People taking part
- 13 people enrolled
- Started
- 14 Apr 2023
- Ended
- 14 Aug 2024
- Type of study
- Observational, 2 groups
- Treatments tested
- Biological sample collection
- Record updated
- 26 September 2024
- Why it stopped
- Study was terminated due to a strategic re-evaluation of the company's overall business and clinical development strategy.
Who can take part
- Age
- 18 years to 125 years
- Sex
- Women only
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 14 criteriaShow less
Who can take part
- 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
Who cannot take part
- Previously study participation
- Anticancer treatment or radiation therapy of the region which is to be drained or biopsied within the last 4 weeks
- Patient is treated with therapeutics not tested in the assay - with the exception of anti-VEGF (Vascular endothelial growth factor) therapy
- Known or suspected HIV or active Hepatitis B and/or C infection or active COVID-19 infection
- Patient unfit or not willing to receive any further systemic treatment
- 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%)
This trial has no sites in United States.
It has sites in 2 countries. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
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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
The 2 groups in the trial
- Newly diagnosed
Newly diagnosed ovarian carcinoma patients presenting with ascites and/or pleural effusions before start of their initial therapy.
Treatment: Biological sample collection
- Relapsed/refractory
Relapsed/refractory (r/r) ovarian carcinoma patients presenting with ascites before start of their next therapy line (for r/r patients).
Treatment: Biological sample collection
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Observational Analysis of the Association of Drug Activity Measured in Viable Tumour Tissues ex Vivo and Clinical Response in Ovarian Cancer: A Basic Research Study
- Record updated
- 26 September 2024