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Epithelial Ovarian CancerEXCYTE-1NCT06068738

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

An observational study of Epithelial Ovarian Cancer, run by Exscientia AI Limited at 4 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 125 years, women only
Conditions the study is for
Epithelial Ovarian Cancer
What is being tested?
Biological sample collection
How many people
13 participants
Where
4 sitesin 2 countries
Study dates
14 Apr 2023to 14 Aug 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 125 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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 join

  • 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%)

Trial locations and contacts

4 sites in 2 countries.

4 sites in 2 countries

Austria2 sites

  • Barmherzige Schwestern Linz, Abteilung Gynäkologie und Geburtshilfe

    Linz, Upper Austria, 4010

  • Med. Universität Wien - Universitätsklinik für Frauenheilkunde

    Vienna, 1090

Other trials in Austria

Germany2 sites

  • Evang. Kliniken Essen-Mitte gGmbH

    Essen, North Rhine-Westphalia, 45136

  • Department für Frauengesundheit/Universitäts-Frauenklinik Tübingen

    Tübingen, 72076

Other trials in Germany

About this study

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

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.

Read more

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
Being tested
Biological sample collection
Medical subject headings
Carcinoma, Ovarian Epithelial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biological sample collectionOther

    Collection of ascites, blood and fresh tumour tissues (if available)

Study groups in NCT06068738
Study groupRoleWhat they receive
Newly diagnosedNewly diagnosed ovarian carcinoma patients presenting with ascites and/or pleural effusions before start of their initial therapy.
Receives: Other: Biological sample collection
Relapsed/refractoryRelapsed/refractory (r/r) ovarian carcinoma patients presenting with ascites before start of their next therapy line (for r/r patients).
Receives: Other: Biological sample collection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Association between ex vivo drug response (EVDR) of ascites samples and clinical outcome

    EVDR will be compared to the clinical outcome, determined based on local practice

    Measured: From time of diagnosis (sampling) until disease progression or End of Study (EoS), whichever comes first, assessed up to 45 month.

Secondary outcomes (3)

  1. Technical success rate

    Percentage of ascites samples meeting inclusion and exclusion criteria that meet the quality criteria as per Exscientia SOPs (Standard Operating Procedures).

    Measured: From study start to study end (up to 45 month).

  2. Prognostic value of EVDR of ascites samples in PFS (Progression-free survival) prediction

    False positive and false negative rate in PFS prediction at 6 and 12 month

    Measured: From diagnosis until month 6 (12) or relapse/ EoS, whatever comes first.

  3. Biomarker impact on EVDR and its prognostic value

    Hazard rate associated with established biomarkers and interaction between these markers and EVDR outcome

    Measured: From study start to study end (up to 45 month).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Oct 2023
  2. Study start14 Apr 2023
  3. Primary completion14 Aug 2024
  4. Study completion14 Aug 2024

Why it stopped: Study was terminated due to a strategic re-evaluation of the company's overall business and clinical development strategy.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06068738
Sponsor's protocol ID
AC2202
Acronym
EXCYTE-1
Status last verified
Sep 2024
First submitted
22 Sep 2023
Last updated
26 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kornauth C, Pemovska T, Vladimer GI, Bayer G, Bergmann M, Eder S, Eichner R, Erl M, Esterbauer H, Exner R, Felsleitner-Hauer V, Forte M, Gaiger A, Geissler K, Greinix HT, Gstottner W, Hacker M, Hartmann BL, Hauswirth AW, Heinemann T, Heintel D, Hoda MA, Hopfinger G, Jaeger U, Kazianka L, Kenner L, Kiesewetter B, Krall N, Krajnik G, Kubicek S, Le T, Lubowitzki S, Mayerhoefer ME, Menschel E, Merkel O, Miura K, Mullauer L, Neumeister P, Noesslinger T, Ocko K, Ohler L, Panny M, Pichler A, Porpaczy E, Prager GW, Raderer M, Ristl R, Ruckser R, Salamon J, Schiefer AI, Schmolke AS, Schwarzinger I, Selzer E, Sillaber C, Skrabs C, Sperr WR, Srndic I, Thalhammer R, Valent P, van der Kouwe E, Vanura K, Vogt S, Waldstein C, Wolf D, Zielinski CC, Zojer N, Simonitsch-Klupp I, Superti-Furga G, Snijder B, Staber PB. Functional Precision Medicine Provides Clinical Benefit in Advanced Aggressive Hematologic Cancers and Identifies Exceptional Responders. Cancer Discov. 2022 Feb;12(2):372-387. doi: 10.1158/2159-8290.CD-21-0538. Epub 2021 Oct 11.

    PubMed 34635570

Questions about this trial

What is this clinical trial studying?

An observational study of Epithelial Ovarian Cancer, run by Exscientia AI Limited at 4 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 26 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Austria, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Study was terminated due to a strategic re-evaluation of the company's overall business and clinical development strategy.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06068738, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2024.

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