CURESPONSE
Research type
Research Study
Full title
Prediction of Patient Drug Response Using an Ex Vivo Organ Culture (EVOC) on fresh human tumour samples from Metastatic Patients
IRAS ID
283442
Contact name
Jonathan Krell
Contact email
Sponsor organisation
Imperial College London and Imperial College NHS Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 2 months, 30 days
Research summary
This study aims to determine how sensitive and specific the Curesponse Ex Vivo Organ Culture (EVOC) model is at predicting a patient’s clinical response to a specific cancer therapy.
Patients over the age of 18 years, who have a suspected or confirmed advanced/metastatic cancer suitable for biopsy and planned for standard systemic treatment e.g. chemotherapy will be eligible to participate, subject to the full inclusion and exclusion criteria in the protocol.
After screening and fulfilling the eligibility criteria, patients will undergo a research biopsy where up to 6 tissue samples will be collected. An optional peripheral blood sample will also be taken providing the patient consents for germline testing. Patients will then attend their hospital clinic to receive treatment considered standard for the location, stage and malignancy grade of the cancer.
Concurrently to the patient’s clinical treatment, the tissue samples will be transported to the Curesponse laboratory for development of an EVOC model. 3D tissue cultures will be grown and treated with a range of drugs, including the treatment being given to the patient in clinic. The model will give a prediction as to whether the cancer will respond to the standard therapy. Additionally, providing the patient provides consent, the tissue will undergo genomic analysis related to secondary and laboratory based study objectives.
The EVOC prediction regarding response to standard therapy will be communicated to the team running the study based at Imperial College London, and compared to the actual, clinical response of the patient assessed by the hospital team looking after them.
248 patients will be recruited from participating UK hospitals and followed up for 6 months following their biopsy. The combined results of the study will show whether the EVOC has the potential to be useful for future patients prospectively, in determining whether standard clinical treatment is likely to benefit them.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
21/YH/0056
Date of REC Opinion
8 Apr 2021
REC opinion
Further Information Favourable Opinion