Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
17994
Study information
Scientific title
Refining Ovarian Cancer Test Accuracy Scores: A test accuracy study to validate new risk scores in women with symptoms of suspected ovarian cancer.
Acronym
ROCkeTS
Study hypothesis
The ROCkeTS project aims to derive and validate new tests/risk prediction models that estimate the probability of having OC in women with symptoms. This project will be conducted in four interlinked phases
1. Phase 1 will be to undertake systematic reviews of the accuracy of tests and risk prediction models used for identifying OC in women with suspected OC.
2. Simultaneously, in phase 2 we will undertake refinement of an existing risk prediction model based on additional predictions within existing large datasets. For phase 2, we have identified 3 datasets, UKCTOCS, UKOPS and International Ovarian Tumour Analysis (IOTA) that are relevant to primary care and secondary care settings in post and premenopausal women.
3. Phase 3 prospective study: Based on the evidence from phases 1 and 2 , the most promising tests and risk prediction models for post and menopausal women will be externally validated, in a prospective study comprising newly presenting premenopausal and postmenopausal patients. In order to conduct this complex project as effectively as possible, we will start recruitment to the phase 3 study and banking of samples from patients concomitant with phases 1 and 2.
4. In Phase 4, we will develop models of pathways and cost comparisons of alternative testing. Pathways will incorporate the differences in patient management guided by different thresholds of the risk prediction models, that inform the minimum predicted probability that flags a diagnosis of OC.
Ethics approval
14/WM/1241
Study design
Non-randomised; Interventional; Design type: Diagnosis
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a participant information sheet
Condition
Topic: Cancer; Subtopic: Gynaecological Cancer; Disease: Ovary/Fallopian tube
Intervention
The new algorithm: The new test will be developed as part of phase 1 and 2 using biomarkers and ultrasound.
Follow Up Length: 12 month(s)
Intervention type
Other
Phase
Drug names
Primary outcome measure
Sensitivity of the new algorithm
Secondary outcome measures
Specificity of the new algorithm
Overall trial start date
05/06/2015
Overall trial end date
01/03/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Pre and postmenopausal women with symptoms of suspected OC
and either:
2. Raised Ca125
3. Abnormal USG
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 2450; UK Sample Size: 2450; Description: 1050 premenopausal women and 1400 postmenopausal women
Participant exclusion criteria
1. USG reveals non ovarian pathology, e.g. fibroids or simple ovarian cysts < 5cm in size (very low risk of malignancy)
2. Patients with normal pelvis USG
3. Patients who decline transvaginal scan
4. Patients unable to provide informed consent
Recruitment start date
05/06/2015
Recruitment end date
01/03/2016
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Birmingham
Birmingham Clinical Trials Unit
Division of Medical Sciences
Robert Aitken Institute
Edgbaston
Birmingham
B15 2TT
United Kingdom
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2016 protocol in: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4985790