ROCkeTS-GEN V2 is a UK-based, multicentre prospective diagnostic accuracy study investigating novel blood-based biomarkers for the earlier diagnosis of ovarian cancer in postmenopausal women. It is a validation study for previously successfully delivered ROCkeTS and ROCkeTS GEN V1 Studies.
The study evaluates circulating tumour DNA (ctDNA) and additional emerging biomarkers measured from blood samples, including plasma, serum, and dried blood spots. These biomarkers are assessed alongside existing standard diagnostic tools, such as serum CA125 and ultrasound-based risk assessment (including IOTA criteria where available), to determine whether they can improve diagnostic accuracy for ovarian cancer.
ROCkeTS-GEN V2 recruits only postmenopausal women, referred to secondary care with symptoms suggestive of ovarian cancer. Participation does not alter the clinical care pathway. All diagnostic tests and management decisions remain entirely at the discretion of the treating clinical team, in line with current NICE and specialty guidelines.
Blood samples are collected at study entry. For participants who proceed to surgery or biopsy as part of routine care, histology or cytology provides the reference standard for diagnosis. For participants who do not undergo surgery or biopsy, clinical outcomes and wellbeing are assessed at 12 months following study entry using hospital records, clinic visits, or telephone follow-up.
For women undergoing surgery, representative tumour tissue blocks are collected to allow comparison between tumour DNA and circulating tumour DNA detected in blood. This supports validation of ctDNA-based approaches and contributes to a translational research resource for future early cancer detection research.
ROCkeTS-GEN V2 is a non-interventional study and does not involve investigational medicinal products. The study aims to improve understanding of how blood-based biomarkers can support earlier and more accurate diagnosis of ovarian cancer, while minimising unnecessary invasive procedures and improving patient outcomes.
Key Points for Participants
- Taking part will not affect your care or treatment
- No extra clinic visits are required
- Blood samples (plasma, serum and dry blood spots) and tumour tissue sample (in case of surgery) are required
- There are no experimental drugs or procedures
- Your data and samples are handled securely and confidentially
- You can withdraw from the study at any time
Download the Study Protocol (v1.0 17.07.2025) for ROCkeTS GEN V2
Download the Participant Information Sheet (v3.0 28.01.2026) for ROCkeTS GEN V2