Ex VIvo DEtermiNed Cancer Therapy

Recruiting

• Conditions: Sarcoma; Glioblastoma; Head and Neck Cancer; Kidney Cancer; Bladder Cancer; Melanoma
• Interventions: Diagnostic Test: Functional drug screen

• Registration Number: NCT05231655
• Lead Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust

Brief 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

Study Timeline

• Study Start: 2021-07-07
• Study First Submitted: 2022-01-31
• Study First Submitted QC: 2022-01-31
• Study First Posted: 2022-02-09
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-20
• Last Update Posted: 2025-02-24
• Primary Completion: 2026-01
• Study Completion: 2027-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

>16 years of age with a diagnosis of known or suspected solid cancer who will undergo surgery, biopsy, aspirate, or TURBT

Willing to donate a section fresh tumour tissue from surgery, a TURBT, fluid aspirate, or biopsy surplus to diagnostic use

Willing to donate a 9ml blood sample

Able to give written informed consent

Previously treated patients are eligible if:

• Present with a recurrence of a previously treated tumour. This may be a local or metastatic recurrence
• Have undergone treatment for their cancer, but fail to respond to this and progress
• Have received neoadjuvant therapy for their tumour
• Have undergone chemotherapy, targeted therapy, immunotherapy, hormone therapy and or radiotherapy for a previous tumour

Exclusion Criteria

Patients with a known diagnosis of a blood borne virus (Hepatitis B, Hepatitis C, HIV). (The laboratories where experiments will be conducted do not have the safety facilities to use material containing these pathogens)

Patients with a current positive COVID-19 infection

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Kidney Cancer	Functional drug screen	-
Melanoma	Functional drug screen	-
Sarcoma	Functional drug screen	-
Bladder Cancer	Functional drug screen	-
Glioblastoma	Functional drug screen	-
Head and Neck Cancer	Functional drug screen	-

Primary Outcome Measures

Name	Time	Method
Functional drug screen	6 years	Collect and functionally screen solid tumours to determine if ex-vivo drug screening can predict effectiveness of standard cytotoxic chemotherapies and targeted inhibitors in solid cancers by correlating ex-vivo results with patients actual response to standard care.

Trial Locations

Locations (1)

Sheffield Teaching Hospitals NHS Foundation Trust; 🇬🇧 Sheffield, South Yorkshire, United Kingdom