Dr Sudha Sundhar (University of Birmingham)
|Funder name / reference number:||National Institute for Health Research (NIHR) Health Technology Assessment (HTA) Programme : reference: 13/13/01, NHS West Midlands REC (14/WM/1241), RG_14-196|
|UKCRN Study portfolio:||ISRCTN17160843|
|Year||January 2015 - 2019 (4 years)|
ROCkeTS study is a single arm prospective cohort diagnostic test accuracy study to evaluate existing & novel risk prediction models for pre and post-menopausal women with symptoms.
A test accuracy study to validate new risk scores in women with symptoms of suspected ovarian cancer protoco
The systematic review and Individual Participant Data (IPD) analysis covers:
- Phase 1- Systematic reviews of literature
- Phase 2 – Interrogation of datasets/samples from UKOPS, UKCTOCS and IOTA to refine model using tests identified in Phase 1
- Phase 3 – Prospective study to validate new models
- Phase 4 – Analysis and Pathways generation
This project aims to identify, derive and validate tests and clinical risk scores (risk predicition models) that estimate the probability of having ovarian cancer (OC) for both post and premenopausal women.
To identify optimal risk thresholds for the models that can guide patient management.
A test accuracy study is different to an effectiveness study in that randomisation of subjects is not involved. It is designed to generate a comparison of measurements obtained by index tests with those obtained by reference standards. In this way the accuracy of index tests can be estimated.
In ROCkeTS, the index test (risk prediction models) will be derived in phases 1 and 2 and validated at the end of the study. Therefore we will collect symptom questionnaires, blood and USG data in the study to be analysed and validated at the end of the study.
The new algorithm: The new test will be developed as part of phase 1 and 2 using biomarkers and ultrasound.
All women participating in the study complete a symptom questionnaire.
Participants will receive the usual care that their doctor has planned for them.