At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Functional drug screen (diagnostic test)
- How long the study runs
- Study runs about 66 months (dates as stated)
- About the drug or intervention
- Functional drug screen — diagnostic test: High-throughput ex-vivo drug screen of cells processed directly from solid tumours to determine sensitivity / resistance profiles
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Observing health over time
- Ages
- 16 Years and over
- Who
- All
- Number of participants
- 600
- Started
- 2021-07-07
- Last checked
- 2025-02
Plain English Summary
What is this study?
- • Testing a new treatment for bladder cancer
- • Clinical study - 600 participants
- • 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
Who can take part?
- • Ages 16 Years and over
- • Diagnosed with bladder cancer
Where?
- • Sheffield - Sheffield Teaching Hospitals NHS Foundation Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
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
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 16 Years and over
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓\>16 years of age with a diagnosis of known or suspected solid cancer who will undergo surgery, biopsy, aspirate, or...
- ✓Willing to donate a section fresh tumour tissue from surgery, a TURBT, fluid aspirate, or biopsy surplus to...
- ✓Willing to donate a 9ml blood sample
- ✓Able to give written agreement to take part
- ✓Previously treated patients are eligible if:
Who cannot take part
- ✗Patients with a current positive COVID-19 infection
See the full criteria
Where Is This Study? (1 UK site)
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield S10 2JF, United Kingdom
How to Get in Touch
Greg Wells, PhD
Sponsor contactCONTACT