RecruitingRecruiting
Ex VIvo DEtermiNed Cancer Therapy
NCT05231655 · Sheffield Teaching Hospitals NHS Foundation Trust
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
Ex Vivo Multi Drug Screening of Solid Tumours to Determine Personalised Therapy Efficacy and Resistance
About this study
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
Eligibility criteria
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
Enrollment target: 600 participants
Age groups: child, adult, older_adult
Timeline
Starts: 2021-07-07
Estimated completion: 2027-01
Last updated: 2025-02-24
Interventions
Diagnostic Test: Functional drug screen
Primary outcomes
- • Functional drug screen (6 years)
Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust · other
With: University of Sheffield
Contacts & investigators
ContactGreg Wells, PhD · contact · g.wells@sheffield.ac.uk · +44 114 215 9098
InvestigatorSarah Danson, PhD, FRCP · principal_investigator, University of Sheffield, Sheffield Teaching Hospitals NHS Foundation Trust
All locations (1)
Sheffield Teaching Hospitals NHS Foundation TrustRecruiting
Sheffield, South Yorkshire, United Kingdom