Ex VIvo DEtermiNed Cancer Therapy

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	16 Years and Over
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05231655
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Sheffield Teaching Hospitals NHS Foundation Trust
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Sarah Danson, PhD, FRCP
Principal Investigator Affiliation	University of Sheffield, Sheffield Teaching Hospitals NHS Foundation Trust
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United Kingdom
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Bladder Cancer, Kidney Cancer, Melanoma, Sarcoma, Glioblastoma, Head and Neck Cancer

Additional Details

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

Arms & Interventions

Arms

: Bladder Cancer

: Kidney Cancer

: Melanoma

: Sarcoma

: Glioblastoma

: Head and Neck Cancer

Interventions

Diagnostic Test: - Functional drug screen

High-throughput ex-vivo drug screen of cells processed directly from solid tumours to determine sensitivity / resistance profiles

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Sheffield, South Yorkshire, United Kingdom

Status

Recruiting

Address

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, South Yorkshire, S10 2JF

Site Contact

Dipak Patel, PhD

[email protected]

+44 114 226 5941

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