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

NCT06068738 | Terminated

• 1 other identifier: AC2202
• Study Type: observational
• Target: 13
• Locations: 2 countries
• Sites: 4

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

Outcome Measures

Primary Outcomes (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

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

Secondary Outcomes (3)

• Technical success rate

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

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

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

• Biomarker impact on EVDR and its prognostic value

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

Study Arms (2)

Newly diagnosed

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

Other: 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).

Other: Biological sample collection

Interventions

Biological sample collection OTHER

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

Newly diagnosed; Relapsed/refractory

Eligibility Criteria

• Age: 18 Years - 125 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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%)

Sponsors & Collaborators

• Exscientia AI Limited: lead
• AGO Research GmbH: collaborator

Study Sites (4)

Barmherzige Schwestern Linz, Abteilung Gynäkologie und Geburtshilfe

Linz, Upper Austria, 4010, Austria

Location

Med. Universität Wien - Universitätsklinik für Frauenheilkunde

Vienna, 1090, Austria

Location

Evang. Kliniken Essen-Mitte gGmbH

Essen, North Rhine-Westphalia, 45136, Germany

Location

Department für Frauengesundheit/Universitäts-Frauenklinik Tübingen

Tübingen, 72076, Germany

Location

Related Publications (1)

• 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.

  PMID: 34635570 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Frozen viable cells from ascites/pleural effusion and blood, optionally from solid tumour tissue.

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Ovarian Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Nikolaus Krall, Dr.

  Exscientia GmbH

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2023
• First Posted: October 5, 2023
• Study Start: April 14, 2023
• Primary Completion: August 14, 2024
• Study Completion: August 14, 2024
• Last Updated: September 26, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2); AU (2)