CTCR-OV05

• Research type

  Research Study

• Full title

  Genetic Biomarkers for Gynaecological Conditions

• IRAS ID

  162625

• Contact name

  Elizabeth Moore

• Sponsor organisation

  Cambridge University Hospitals NHS Foundation Trust and The University of Cambridge

• Duration of Study in the UK

  2 years, 7 months, 30 days

• Research summary

  Ovarian cancer (OC) is the fifth most common cancer in women in the UK. Due to the non-specific symptoms of OC the disease tends to present late. 5-year survival rates are 43% overall but are over 90% for early stage tumours. Currently, national guidelines dictate that all patients with a suspected OC are triaged using a blood test and pelvic ultrasound imaging to calculate a Risk of Malignancy Index (RMI). Due to the current difficulties of early diagnosis of OC and poor outcome in patients diagnosed with late stage disease much work is currently being done to identify new biomarkers that can potentially be used to improve OC triage and can subsequently be used in population screening for OC. Somatic mutations are highly specific biomarkers of cancer. It has already been shown that somatic mutations can be identified in blood samples from patients with advanced OC. We propose to look at somatic mutations in blood and cervical samples from women referred from primary care with suspected ovarian cancer. If such mutations could be detected at the time of diagnosis this could theoretically be a non-invasive method for cancer diagnosis that could potentially increase the early detection of such cancers and thereby improve disease outcome. We also propose to look at somatic mutations in blood and cervical samples from those patients subsequently undergoing surgery for OC. It is known that there is a relationship between the extent of surgical resection and survival however, there is currently no objective measure of tumour burden and post-operative residual disease. Somatic mutations could be used as an indicator of residual disease, degree of surgical resection and serial monitoring could be used as a marker of response to treatment thereby guiding future monitoring and treatment.

• REC name

  East of England - Cambridge East Research Ethics Committee

• REC reference

  14/EE/1248

• Date of REC Opinion

  18 Mar 2015

• REC opinion

  Further Information Favourable Opinion