Clinical trial NCT05231655: Ex VIvo DEtermiNed Cancer Therapy
Official title: Ex Vivo Multi Drug Screening of Solid Tumours to Determine Personalised Therapy Efficacy and Resistance
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bladder Cancer
Kidney Cancer
Melanoma
Sarcoma
Glioblastoma
Head and Neck Cancer
Keywords: Personalized medicine
Ex vivo drug screen
Image based analysis
Lead sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University of Sheffield
First posted: 2022-02-09
Enrollment: 600
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All participants who fit the eligibility criteria who are currently under the care of 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

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

Primary outcomes:
measure: Functional drug screen
timeFrame: 6 years
Secondary outcomes:
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospitals NHS Foundation Trust
state: South Yorkshire
Study officials:
affiliation: University of Sheffield, Sheffield Teaching Hospitals NHS Foundation Trust
name: Sarah Danson, PhD, FRCP
role: PRINCIPAL_INVESTIGATOR
References: