Ex VIvo DEtermiNed Cancer Therapy (EVIDENT)

  • STATUS
    Recruiting
  • End date
    Jan 25, 2027
  • participants needed
    600
  • sponsor
    Sheffield Teaching Hospitals NHS Foundation Trust
Updated on 25 March 2022
cancer
hormone therapy
cancer chemotherapy
solid tumour
targeted therapy

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

Details
Condition Bladder Cancer, Kidney Cancer, Melanoma, Sarcoma, Glioblastoma, Head and Neck Cancer
Treatment Functional drug screen
Clinical Study IdentifierNCT05231655
SponsorSheffield Teaching Hospitals NHS Foundation Trust
Last Modified on25 March 2022

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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