| NCT ID | NCT05231655 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sheffield Teaching Hospitals NHS Foundation Trust |
| Condition | Bladder Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 600 participants |
| Start Date | 2021-07-07 |
| Primary Completion | 2026-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 600 participants in total. It began in 2021-07-07 with a primary completion date of 2026-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Sarah Danson, PhD, FRCP
PRINCIPAL INVESTIGATOR
University of Sheffield, Sheffield Teaching Hospitals NHS Foundation Trust
Frequently Asked Questions
Who can join the NCT05231655 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, studying Bladder Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05231655 currently recruiting?
Yes, NCT05231655 is actively recruiting participants. Contact the research team at g.wells@sheffield.ac.uk for enrollment information.
Where is the NCT05231655 trial being conducted?
This trial is being conducted at Sheffield, United Kingdom.
Who is sponsoring the NCT05231655 clinical trial?
NCT05231655 is sponsored by Sheffield Teaching Hospitals NHS Foundation Trust. The principal investigator is Sarah Danson, PhD, FRCP at University of Sheffield, Sheffield Teaching Hospitals NHS Foundation Trust. The trial plans to enroll 600 participants.
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