NCT05231655

Ex VIvo DEtermiNed Cancer Therapy

Ex Vivo Multi Drug Screening of Solid Tumours to Determine Personalised Therapy Efficacy and Resistance

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 600 (estimated)
• Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

EVIDENT's aim is to test if ex vivo drug screening can predict whether patients with solid cancers will respond, or not respond, to standard care treatments. Patients undergoing standard care surgery to excise their tumour, those undergoing a biopsy, or those having a fluid aspirate of a solid tumour with surplus tissue available after diagnostic use will be eligible for this study. The specimen will then be assessed with ex vivo drug screening utilising all standard therapies and therapies that are more novel and in early stages of development. The results of the ex vivo drug screen will be compared to the cancer's actual response to standard care treatments for those that undergo therapy to determine how effective the test is at predicting treatment response.

Detailed description

The EVIDENT study is a feasibility / proof of concept study which is designed to determine if ex vivo screening of a patient's solid tumour can predict the effectiveness of standard cytotoxic chemotherapies and targeted inhibitors in solid cancers prior to the patients treatment. We aim to recruit 100 patient to each group starting with the six currently listed, but leave scope to add new groups of different solid cancers in the future. EVIDENT aims: * Demonstrate the feasibility of collecting fresh tumour samples within the NHS from patients with solid tumours for ex vivo screening * Demonstrate that tumour response to drug exposure can be measured and quantified within an ex vivo screening platform * Collect the participants' clinical outcome data (tumour response and progression free survival) to their standard of care treatment regimes and correlate with results from the ex vivo drug screen * Identify novel effective therapies * Investigate the tumour biopsies derived omics to determine the strength of well-established, less well-established biomarkers, and to identify novel biomarkers through correlation with the ex vivo drug screen results

Conditions

• Bladder Cancer
• Kidney Cancer
• Melanoma
• Sarcoma
• Glioblastoma
• Head and Neck Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Functional drug screen	High-throughput ex-vivo drug screen of cells processed directly from solid tumours to determine sensitivity / resistance profiles

Timeline

• Start date: 2021-07-07
• Primary completion: 2026-01-01
• Completion: 2027-01-01
• First posted: 2022-02-09
• Last updated: 2025-02-24

Locations

1 site across 1 country: United Kingdom