RecruitingNCT05231655

Ex VIvo DEtermiNed Cancer Therapy

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


Sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

Enrollment

600 participants

Start Date

Jul 7, 2021

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 16 Years

Inclusion Criteria9

  • \>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 Criteria2

  • 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

Interventions

DIAGNOSTIC_TESTFunctional drug screen

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


Locations(1)

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, South Yorkshire, United Kingdom

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NCT05231655


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