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| Name | Class |
|---|---|
| University of Sheffield | OTHER |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bladder Cancer |
| ||
| Kidney Cancer |
| ||
| Melanoma |
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| Sarcoma |
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| Glioblastoma |
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| Head and Neck Cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Functional drug screen | Diagnostic Test | High-throughput ex-vivo drug screen of cells processed directly from solid tumours to determine sensitivity / resistance profiles |
|
| 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 |
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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:
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
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All participants who fit the eligibility criteria who are currently under the care of Sheffield Teaching Hospitals NHS Foundation Trust
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Greg Wells, PhD | Contact | +44 114 215 9098 | g.wells@sheffield.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Sarah Danson, PhD, FRCP | University of Sheffield, Sheffield Teaching Hospitals NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sheffield Teaching Hospitals NHS Foundation Trust | Recruiting | Sheffield | South Yorkshire | S10 2JF | United Kingdom |
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| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| D007680 | Kidney Neoplasms |
| D008545 | Melanoma |
| D012509 | Sarcoma |
| D005909 | Glioblastoma |
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Specimens will be retained for the duration of the study where surplus tissue is available
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D007674 | Kidney Diseases |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D009375 | Neoplasms, Glandular and Epithelial |