ROCkeTS: Refining Ovarian Cancer Test Accuracy Scores
| ISRCTN | ISRCTN17160843 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17160843 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 168143 |
| Protocol serial number | CPMS 17994, IRAS 168143, RG_14-196 |
| Sponsor | University of Birmingham |
| Funder | National Institute for Health Research |
- 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
Contact information
Mr Ryan Ottridge
Public
Public
University of Birmingham
Birmingham Clinical Trials Unit
Public Health Building
Birmingham
B15 2TT
United Kingdom
| Phone | +44 121 415 9127 |
|---|---|
| r.ottridge@bham.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Non-randomised; Interventional; Design type: Diagnosis |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| 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. |
| Study acronym | ROCkeTS |
| Study objectives | 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(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) studied | 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 |
| Primary outcome measure(s) |
Sensitivity of the new algorithm |
| Key secondary outcome measure(s) |
Specificity of the new algorithm |
| Completion date | 31/10/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 2450 |
| Key inclusion criteria | 1. Pre and postmenopausal women with symptoms of suspected OC and either: 2. Raised Ca125 3. Abnormal USG |
| Key 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 |
| Date of first enrolment | 05/06/2015 |
| Date of final enrolment | 31/03/2023 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
University of Birmingham
Birmingham Clinical Trials Unit
Division of Medical Sciences
Robert Aitken Institute
Edgbaston
Birmingham
B15 2TT
United Kingdom
Division of Medical Sciences
Robert Aitken Institute
Edgbaston
Birmingham
B15 2TT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/10/2024 | 04/10/2024 | Yes | No | |
| Protocol article | protocol | 09/08/2016 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
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
