Ex VIvo DEtermiNed Cancer Therapy

Study Overview
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Brief Summary
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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
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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

Official Title
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Ex Vivo Multi Drug Screening of Solid Tumours to Determine Personalised Therapy Efficacy and Resistance

Conditions
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Bladder Cancer, Kidney Cancer, Melanoma, Sarcoma, Glioblastoma, Head and Neck Cancer

Intervention / Treatment
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* Diagnostic Test: Functional drug screen


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Bladder Cancer<br> | Diagnostic Test: Functional drug screen<br>* High-throughput ex-vivo drug screen of cells processed directly from solid tumours to determine sensitivity / resistance profiles<br>|
| Kidney Cancer<br> | Diagnostic Test: Functional drug screen<br>* High-throughput ex-vivo drug screen of cells processed directly from solid tumours to determine sensitivity / resistance profiles<br>|
| Melanoma<br> | Diagnostic Test: Functional drug screen<br>* High-throughput ex-vivo drug screen of cells processed directly from solid tumours to determine sensitivity / resistance profiles<br>|
| Sarcoma<br> | Diagnostic Test: Functional drug screen<br>* High-throughput ex-vivo drug screen of cells processed directly from solid tumours to determine sensitivity / resistance profiles<br>|
| Glioblastoma<br> | Diagnostic Test: Functional drug screen<br>* High-throughput ex-vivo drug screen of cells processed directly from solid tumours to determine sensitivity / resistance profiles<br>|
| Head and Neck Cancer<br> | Diagnostic Test: Functional drug screen<br>* High-throughput ex-vivo drug screen of cells processed directly from solid tumours to determine sensitivity / resistance profiles<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Personalized medicine, Ex vivo drug screen, Image based analysis