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

January 8, 2024 updated by: Exscientia GmbH

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Recruiting
        • Med. Universität Wien - Universitätsklinik für Frauenheilkunde
    • Upper Austria
      • Linz, Upper Austria, Austria, 4010
        • Recruiting
        • Barmherzige Schwestern Linz, Abteilung Gynäkologie und Geburtshilfe
  • Germany
    • North Rhine-Westphalia
      • Essen, North Rhine-Westphalia, Germany, 45136
        • Recruiting
        • Evang. Kliniken Essen-Mitte gGmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

The study will enroll newly diagnosed patients with advanced ovarian cancer (FIGO III and FIGO IV) where ascites can be collected during a routine primary debulking surgery, or patients with relapsed (1st, 2nd and 3rd relapse) ovarian cancer scheduled to undergo routine drainage of malignant ascites.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Newly diagnosed
Newly diagnosed ovarian carcinoma patients presenting with ascites and/or pleural effusions before start of their initial therapy.
Other: Biological sample collection
Collection of ascites, blood and fresh tumour tissues (if available)
Relapsed/refractory
Relapsed/refractory (r/r) ovarian carcinoma patients presenting with ascites before start of their next therapy line (for r/r patients).
Other: Biological sample collection
Collection of ascites, blood and fresh tumour tissues (if available)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association between ex vivo drug response (EVDR) of ascites samples and clinical outcome
Time Frame: 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
From time of diagnosis (sampling) until disease progression or End of Study (EoS), whichever comes first, assessed up to 45 month.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technical success rate
Time Frame: 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).
From study start to study end (up to 45 month).
Prognostic value of EVDR of ascites samples in PFS (Progression-free survival) prediction
Time Frame: 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
From diagnosis until month 6 (12) or relapse/ EoS, whatever comes first.
Biomarker impact on EVDR and its prognostic value
Time Frame: From study start to study end (up to 45 month).
Hazard rate associated with established biomarkers and interaction between these markers and EVDR outcome
From study start to study end (up to 45 month).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Exscientia GmbH

Collaborators

AGO Research GmbH

Investigators

  • Study Director: Nikolaus Krall, Dr., Exscientia GmbH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 14, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

September 22, 2023

First Submitted That Met QC Criteria

September 28, 2023

First Posted (Actual)

October 5, 2023

Study Record Updates

Last Update Posted (Actual)

January 9, 2024

Last Update Submitted That Met QC Criteria

January 8, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AC2202

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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