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

NCT ID: NCT06068738

Last Updated: 2024-09-26

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 13 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-04-14
• Study Completion Date: 2024-08-14

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, 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

Conditions

Epithelial Ovarian Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Newly diagnosed

Newly diagnosed ovarian carcinoma patients presenting with ascites and/or pleural effusions before start of their initial therapy.

Biological sample collection

Intervention Type: OTHER

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).

Biological sample collection

Intervention Type: OTHER

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

Interventions

Biological sample collection

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

Intervention Type: OTHER

Eligibility Criteria

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%)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 125 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

AGO Research GmbH

INDUSTRY

Sponsor Role: collaborator

Exscientia AI Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nikolaus Krall, Dr.

Role: STUDY_DIRECTOR

Exscientia GmbH

Locations

Barmherzige Schwestern Linz, Abteilung Gynäkologie und Geburtshilfe

Linz, Upper Austria, Austria

Med. Universität Wien - Universitätsklinik für Frauenheilkunde

Vienna, , Austria

Evang. Kliniken Essen-Mitte gGmbH

Essen, North Rhine-Westphalia, Germany

Department für Frauengesundheit/Universitäts-Frauenklinik Tübingen

Tübingen, , Germany

Countries

Austria; Germany

References

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.

Reference Type: BACKGROUND

PMID: 34635570 (View on PubMed)

Other Identifiers

AC2202

Identifier Type: -

Identifier Source: org_study_id