ROCkeTS: Refining Ovarian Cancer Test Accuracy Scores | Not Recruiting
ROCkeTS: Refining Ovarian Cancer Te... | Not Recruiting
ROCkeTS: Refining Ovarian Cancer Test Accuracy Scores
ROCkeTS

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Medical Conditions
  • Topic: Cancer
  • Subtopic: Gynaecological Cancer
  • Disease: Ovary/Fallopian tube
Primary Contact Details
Mr Francis Dowling
See all trial contact details
Recruitment Status
Not Recruiting
Trial source and source ID number
ISRCTN17160843
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Summary
http://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-looking-at-current-tests-for-ovarian-cancer-to-help-improve-diagnosis-rockets
Research Details
  • 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.
Phase
Sorry, this information is not available
Study Design
Non-randomised; Interventional; Design type: Diagnosis
Study Type
Interventional
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 Measures
    Sensitivity of the new algorithm
Secondary Outcome Measures
    Specificity of the new algorithm
Publication(s)
Sorry, this information is not available
Result Reports
Sorry, this information is not available
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Both
Age Range
Adult
Who Can Participate
Patient
Number of Participants
Planned Sample Size: 2450; UK Sample Size: 2450; Description: 1050 premenopausal women and 1400 postmenopausal women
Participant Inclusion Criteria
    1. Pre and postmenopausal women with symptoms of suspected OC
    and either:
    2. Raised Ca125
    3. Abnormal USG
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
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Pfizer Investigational Site
Birmingham
B15 2TT
Trial Contact(s)
Primary Trial Contact
Mr Francis Dowling
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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.
EudraCT Number
Sorry, this information is not available
Funder(s)
  • National Institute for Health Research
Other Study ID Numbers
17994
Sponsor(s)
University of Birmingham
Key Dates

Recruitment Start Date

05 Jun 2015

Recruitment End Date

01 Mar 2016

Trial Start Date

05 Jun 2015

Trial End Date

01 Mar 2016

Date added to source

03 Jun 2015

Date updated in source

01 Oct 2015