Ovarian cancer Cancer
Conditions
Interventions
ROCkeTS GEN V2 study is a prospective single-arm cohort diagnostic accuracy study where all patients receive all tests, and accuracy of tests is evaluated against a gold standard of histology or 12-mo
Sponsors
University of Birmingham
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Post menopausal, symptomatic women presenting to primary care with suspected ovarian cancer who are tested for the biomarker CA125 according to current standards of care for investigation of CA125 in the primary care setting. 2. Women referred with symptoms of suspected OC (typical referral symptoms are defined in section 2.5 of the protocol). 3. Only postmenopausal women are included. Menopause is defined as > 12 months without menstruation. Those no longer menstruating > 12 months for reasons such as contraception or hysterectomy should have their menopausal status categorised according to age; < 50 years premenopausal, 51+ years postmenopausal. 4. In addition, women must have test results from one of the following: 4.1. A raised Ca125 test result (even if imaging has not been done yet) 4.2. Abnormal imaging result showing a lesion (even if CA125 test is not raised). 4.3. Both a raised CA125 test and an abnormal imaging result showing a lesion 5. Patients able to provide informed consent.
Exclusion criteria
Exclusion criteria: 1. Premenopausal women 2. USG reveals simple ovarian cysts < 5cm in size (very low risk of malignancy) and patient does not have a raised CA125. 3. Previous ovarian malignancy. 4. Active non-ovarian malignancy – Women with a past history of cancer are only eligible if there are no documented persistent or recurrent disease and they have not received treatment for this in the last 12 months. This exclusion does not apply to patients with premalignant disease e.g. cervical intra-epithelial neoplasia or patients receiving Tamoxifen/other drugs to prevent breast cancer recurrence.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Sensitivity of ctDNA for detecting early-stage (stage I/II) high-grade serous ovarian cancer is measured using ctDNA analysis at baseline 2. Specificity of ctDNA for detecting early-stage (stage I/II) high-grade serous ovarian cancer is measured using ctDNA analysis at baseline 3. Sensitivity of RMI 1 for detecting early-stage (stage I/II) high-grade serous ovarian cancer is measured using RMI 1 score at baseline 4. Specificity of RMI 1 for detecting early-stage (stage I/II) high-grade serous ovarian cancer is measured using RMI 1 score at baseline 5. Histology or cytology confirmation of ovarian cancer status is measured using pathology review at surgery or biopsy 6. Cancer or non-cancer outcome status is measured using hospital records at 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| There are no secondary outcome measures | — |
Countries
United Kingdom
Contacts
Public ContactSudha Sundar
Outcome results
None listed