ROCkeTS: Refining Ovarian Cancer Test Accuracy Scores

ISRCTN ISRCTN17160843
DOI https://doi.org/10.1186/ISRCTN17160843
IRAS number 168143
Secondary identifying numbers CPMS 17994, IRAS 168143, RG_14-196
Submission date
03/06/2015
Registration date
03/06/2015
Last edited
04/10/2024
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

http://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-looking-at-current-tests-for-ovarian-cancer-to-help-improve-diagnosis-rockets

Study website

Contact information

Mr Ryan Ottridge
Public

University of Birmingham
Birmingham Clinical Trials Unit
Public Health Building
Birmingham
B15 2TT
United Kingdom

Phone +44 121 415 9127
Email r.ottridge@bham.ac.uk

Study information

Study designNon-randomised; Interventional; Design type: Diagnosis
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a participant information sheet
Scientific titleRefining Ovarian Cancer Test Accuracy Scores: A test accuracy study to validate new risk scores in women with symptoms of suspected ovarian cancer.
Study acronymROCkeTS
Study objectivesThe 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(s)Approved 30/12/2014, NRES Committee West Midlands - Solihull (The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS, UK; +44 207 104 8269; solihull.rec@hra.nhs.uk), ref: 14/WM/1241
Health condition(s) or problem(s) studiedTopic: Cancer; Subtopic: Gynaecological Cancer; Disease: Ovary/Fallopian tube
InterventionThe 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 typeOther
Primary outcome measureSensitivity of the new algorithm
Secondary outcome measuresSpecificity of the new algorithm
Overall study start date05/06/2015
Completion date31/10/2023

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participantsPlanned Sample Size: 2450; UK Sample Size: 2450; Description: 1050 premenopausal women and 1400 postmenopausal women
Key inclusion criteria1. Pre and postmenopausal women with symptoms of suspected OC
and either:
2. Raised Ca125
3. Abnormal USG
Key exclusion criteria1. 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
Date of first enrolment05/06/2015
Date of final enrolment31/03/2023

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

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

Sponsor information

University of Birmingham
University/education

Research Support Services – Research Governance
Birmingham
B15 2TT
England
United Kingdom

Email researchgovernance@contacts.bham.ac.uk
ROR logo "ROR" https://ror.org/03angcq70

Funders

Funder type

Government

National Institute for Health Research
Government organisation / National government
Alternative name(s)
National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location
United Kingdom

Results and Publications

Intention to publish date31/10/2024
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing planNot provided at time of registration

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 09/08/2016 Yes No
HRA research summary 28/06/2023 No No
Results article 01/10/2024 04/10/2024 Yes No

Editorial Notes

04/10/2024: Publication reference added.
20/03/2023: The following changes were made to the trial record:
1. The contact was changed.
2. The CPMS and IRAS numbers were added.
3. The ethics approval was added.
4. The recruitment end date was changed from 01/03/2016 to 31/03/2023.
5. The overall end date was changed from 01/03/2016 to 31/10/2023.
6. The sponsor details were updated.
07/05/2021: Proactive update review. Added trial website.
22/02/2018: Publication reference added