An observational study in Epithelial Ovarian Cancer, sponsored by Exscientia AI Limited. Terminated at 4 sites in 2 countries. Open to female participants aged 18 Years to 125 Years. Per ClinicalTrials.gov, last updated 2024-09-26.
Sponsored by Exscientia AI Limited · Observational
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:
2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.
This study's enrollment of 13 is below the median of 200 across 527 observational studies indexed under Ovarian Neoplasms.
Browse Ovarian Neoplasms studies →Exscientia AI Limited is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Newly diagnosed ovarian carcinoma patients presenting with ascites and/or pleural effusions before start of their initial therapy.
Other: Biological sample collection
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)
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
Time frame: From time of diagnosis (sampling) until disease progression or End of Study (EoS), whichever comes first, assessed up to 45 month.
Technical success rate
Percentage of ascites samples meeting inclusion and exclusion criteria that meet the quality criteria as per Exscientia SOPs (Standard Operating Procedures).
Time frame: From study start to study end (up to 45 month).
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
Time frame: From diagnosis until month 6 (12) or relapse/ EoS, whatever comes first.
Biomarker impact on EVDR and its prognostic value
Hazard rate associated with established biomarkers and interaction between these markers and EVDR outcome
Time frame: From study start to study end (up to 45 month).
Plan to share: No
This study is terminated, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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Exscientia AI Limited