2X-1000 Drug Response Predictor (DRP®) Pre-screening
Research type
Research Study
Full title
Development of Drug Response Predictor (DRP) to Test Sensitivity to Investigational Anti-Cancer Drugs in Patients With Advanced Ovarian Cancer
IRAS ID
284271
Contact name
Rebecca Kristeleit
Contact email
Sponsor organisation
Oncology Venture
Clinicaltrials.gov Identifier
CRO Number, SMR-3784
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
This is a multi-National (UK and US), multi-centre (2 sites), open non interventional study to identify ovarian cancer patients who are likely respond to treatment with investigational cancer drugs using a an investigational screening test (Drug Response Predictor - DRP®). The test will use Ribonucleic acid (RNA) (the nucleic acid that is used in key metabolic processes for all steps of protein synthesis in all living cells) isolated from ovarian tumour tissue(archived biopsy tissue or new biopsy tissue) to obtain the gene expression data of the tumour and the predicted response to treatment with investigational cancer drugs.
Most ovarian tumours are diagnosed in an advanced stage with associated poor prognosis for the patients. For ovarian cancer patients at stage III, i.e. tumour growth beyond the affected ovary engaging the peritoneal cavity, the relapse rate is very high. The majority of patients experience disease recurrence and receive second-line and often several lines of treatment, therefore it is clear that there is an unmet need for the identification and clinical validation of new effective treatments accompanied by predictive biomarkers allowing a targeted approach in the management of relapsed ovarian cancer patients.
A total of 100 eligible patients will be included in this study. After providing consent a new biopsy of tumour tissue will be collected if archived tumour tissue is not available and the tumour tissue will be screened using the DRP test.
This study does not involve treatment but will only identify patients with ovarian cancer likely to respond to investigational cancer drugs. If the patient is found to be likely to respond to an investigational cancer drug, they will be offered the chance to participate in the main research study (with investigational drug) within 2 weeks.REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
20/EM/0283
Date of REC Opinion
6 Jan 2021
REC opinion
Further Information Favourable Opinion