Condition category
Cancer
Date applied
03/06/2015
Date assigned
03/06/2015
Last edited
01/10/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Public

Primary contact

Mr Francis Dowling

ORCID ID

Contact details

University of Birmingham
Birmingham Clinical Trials Unit
Division of Medical Sciences
Robert Aitken Institute
Edgbaston
Birmingham
B15 2TT
United Kingdom

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 measures

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

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

Sponsor information

Organisation

University of Birmingham

Sponsor details

Department of Public Health & Epidemiology
Edgbaston
Birmingham
B15 2TT
United Kingdom

Sponsor type

University/education

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes