Bladder CancerEVIDENTNCT05231655
Ex VIvo DEtermiNed Cancer Therapy
An observational study of Bladder Cancer and Kidney Cancer, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Bladder Cancer, Kidney Cancer, Melanoma
- What is being tested?
- Functional drug screen
- How many people
- 600 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 Jul 2021to Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All participants who fit the eligibility criteria who are currently under the care of Sheffield Teaching Hospitals NHS Foundation Trust
Who may be able to join
- >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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, South Yorkshire, S10 2JF
Dipak Patel, PhD, +44 114 226 5941, dipak.patel12@nhs.net
About this study
Official title: Ex Vivo Multi Drug Screening of Solid Tumours to Determine Personalised Therapy Efficacy and Resistance
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.
Read the 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
- Being tested
- Functional drug screen
- Keywords
- Personalized medicine, Ex vivo drug screen, Image based analysis
- Medical subject headings
- Urinary Bladder Neoplasms, Kidney Neoplasms, Melanoma, Sarcoma, Glioblastoma, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional drug screenDiagnostic test
High-throughput ex-vivo drug screen of cells processed directly from solid tumours to determine sensitivity / resistance profiles
| Study group | Role | What they receive |
|---|---|---|
| Bladder Cancer | Not described Receives: Diagnostic Test: Functional drug screen | |
| Kidney Cancer | Not described Receives: Diagnostic Test: Functional drug screen | |
| Melanoma | Not described Receives: Diagnostic Test: Functional drug screen | |
| Sarcoma | Not described Receives: Diagnostic Test: Functional drug screen | |
| Glioblastoma | Not described Receives: Diagnostic Test: Functional drug screen | |
| Head and Neck Cancer | Not described Receives: Diagnostic Test: Functional drug screen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional drug screen
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.
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2022
- Study start7 Jul 2021
- Primary completionJan 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sheffield
- Responsible party
- Sponsor
- Investigators
- Sarah Danson, PhD, FRCP, Principal investigator, University of Sheffield, Sheffield Teaching Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05231655
- Sponsor's protocol ID
- STH20854
- Acronym
- EVIDENT
- Status last verified
- Feb 2025
- First submitted
- 31 Jan 2022
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ex Vivo Multi Drug Screening of Solid Tumours to Determine Personalised Therapy Efficacy and Resistance
- ClinicalTrials.gov ID
- NCT05231655
- Acronym / sponsor ID
- EVIDENT / STH20854
- Conditions
- Bladder Cancer, Kidney Cancer, Melanoma, Sarcoma, Glioblastoma, Head and Neck Cancer
- Keywords
- Personalized medicine, Ex vivo drug screen, Image based analysis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Sheffield
- Study start
- 7 Jul 2021 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 9 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Bladder Cancer | – | Diagnostic Test: Functional drug screen |
| Kidney Cancer | – | Diagnostic Test: Functional drug screen |
| Melanoma | – | Diagnostic Test: Functional drug screen |
| Sarcoma | – | Diagnostic Test: Functional drug screen |
| Glioblastoma | – | Diagnostic Test: Functional drug screen |
| Head and Neck Cancer | – | Diagnostic Test: Functional drug screen |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All participants who fit the eligibility criteria who are currently under the care of Sheffield Teaching Hospitals NHS Foundation Trust
Key inclusion criteria (9 listed)
- >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
- Present with a recurrence of a previously treated tumour. This may be a local or metastatic recurrence
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional drug screenHigh-throughput ex-vivo drug screen of cells processed directly from solid tumours to determine sensitivity / resistance profiles | Diagnostic test | Bladder Cancer, Glioblastoma, Head and Neck Cancer, Kidney Cancer, Melanoma, Sarcoma |
Primary outcome
Functional drug screen
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sarah Danson, PhD, FRCP principal investigator
University of Sheffield, Sheffield Teaching Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Cancer and Kidney Cancer, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Greg Wells, PhD (+44 114 215 9098, g.wells@sheffield.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional drug screen (time frame: 6 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2025.