ROCkeTS GEN V2 Study

• Research type

  Research Study

• Full title

  Refining Ovarian Cancer Test Accuracy Scores: A test accuracy study to validate new risk scores in postmenopausal women with symptoms of suspected ovarian cancer. ROCkeTS GEN V2.

• IRAS ID

  354933

• Contact name

  Sudha Sundar

• Contact email

  s.s.sundar@bham.ac.uk

• Sponsor organisation

  University of Birmingham

• Duration of Study in the UK

  3 years, 9 months, 31 days

• Research summary

  We know that lots of women have symptoms such as bloating and tummy discomfort. It is also very common to have cysts on women’s ovaries picked up by ultrasound. In addition, some women have higher levels of a CA125: this blood test is abnormal in lots of conditions. A very small number of women with ovarian cysts or abnormal CA125 will go on to be diagnosed with ovarian cancer. Ovarian cancer (OC) has an annual incidence of 7500 women and causes 4100 deaths annually in the UK; the lifetime risk of developing OC is 1 in 56. 70% of patients will present at advanced stage and all stage, 5 year survival rate is around 45%. OC is predominantly a disease of older, post-menopausal women, however 1000 women under 50 will be diagnosed with OC annually.
  The purpose of this study is to identify better tests for women with ovarian cysts or abnormal blood test for an earlier diagnosis of the ovarian cancer. This will reduce unnecessary tests, hospital visits and distress in women who don’t have cancer. Patients entering the study will donate a sample of blood. From patients who undergo surgery representative tissue block will be collected for DNA isolation. Earlier diagnosis of cancer has great potential to reduce mortality and morbidity. Recent technological advances allow tiny amounts of cancer signals including tumour-derived DNA and protein markers to be detected in blood samples. There is a need to expand our understanding of the relationship between early cancer development and its representation in circulating tumour DNA (ctDNA) in blood plasma, to allow us to develop better analysis and detection tools for the future. ROCkeTS GEN validation study 2 evaluates ctDNA as a diagnostic test for ovarian cancer in women with non-specific abdominal symptoms.

• REC name

  East Midlands - Derby Research Ethics Committee

• REC reference

  25/EM/0200

• Date of REC Opinion

  11 Sep 2025

• REC opinion

  Further Information Favourable Opinion