Ex VIvo DEtermiNed Cancer Therapy

Head and Neck Cancer Clinical Trial

— EVIDENT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05231655
• Other study ID #: STH20854
• Status: Recruiting
• Start date: July 7, 2021
• Est. completion date: January 2027

Study information

• Verified date: June 2023
• Source: Sheffield Teaching Hospitals NHS Foundation Trust
• Contact: Greg Wells, PhD
• Phone: +44 114 215 9098
• Email: g.wells[@]sheffield.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: January 2027
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bladder Cancer
• Glioblastoma
• Head and Neck Cancer
• Kidney Cancer
• Kidney Neoplasms
• Melanoma
• Sarcoma

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Sheffield Teaching Hospitals NHS Foundation Trust	Sheffield	South Yorkshire

Sponsors (2)

Lead Sponsor	Collaborator
Sheffield Teaching Hospitals NHS Foundation Trust	University of Sheffield

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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