Ex VIvo DEtermiNed Cancer Therapy

NCT05231655 | Recruiting

• 1 other identifier: STH20854
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Bladder Cancer; Kidney Cancer; Melanoma; Sarcoma; Glioblastoma; Head and Neck Cancer

Keywords

Personalized medicine; Ex vivo drug screen; Image based analysis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (6)

Bladder Cancer

Diagnostic Test: Functional drug screen

Kidney Cancer

Diagnostic Test: Functional drug screen

Melanoma

Diagnostic Test: Functional drug screen

Sarcoma

Diagnostic Test: Functional drug screen

Glioblastoma

Diagnostic Test: Functional drug screen

Head and Neck Cancer

Diagnostic Test: Functional drug screen

Interventions

Functional drug screen DIAGNOSTIC_TEST

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

Bladder Cancer; Glioblastoma; Head and Neck Cancer; Kidney Cancer; Melanoma; Sarcoma

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• \>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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead
• University of Sheffield: collaborator

Study Sites (1)

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, South Yorkshire, S10 2JF, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Specimens will be retained for the duration of the study where surplus tissue is available

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Kidney Neoplasms; Melanoma; Sarcoma; Glioblastoma; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Kidney Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Neoplasms, Connective and Soft Tissue; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neoplasms, Glandular and Epithelial

Study Officials

• Sarah Danson, PhD, FRCP

  University of Sheffield, Sheffield Teaching Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Greg Wells, PhD

CONTACT

+44 114 215 9098; g.wells@sheffield.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2022
• First Posted: February 9, 2022
• Study Start: July 7, 2021
• Primary Completion: January 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: February 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)