Endometrial cancer Cancer
Conditions
Interventions
The study intervention is a regular ThinPrep® cell sample of the cervix using a Cervex-Brush® (Rovers Medical Devices) taken by the clinician prior to the ultrasound scan. A standard Cusco speculum wi
Sponsors
University College London
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women aged 45 years or above 2. Abnormal vaginal bleeding warranting an ultrasound examination 3. Women receiving hormonal contraception, hormone replacement therapy, or other hormonal medications, such as Tamoxifen
Exclusion criteria
Exclusion criteria: 1. Women aged below 45 years 2. Pregnancy 3. Previous hysterectomy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The 'real world' performance (sensitivity, specificity, positive and negative predictive values) of the WID™-qEC test in comparison with transvaginal ultrasound (TVUS) as a first-line triage for a cohort of women =45 years who present to a tertiary referral centre with abnormal vaginal bleeding. Receiver operating characteristic curves, areas under the curve, and corresponding 95% confidence intervals will be generated for both TVUS triage (according to an endometrial thickness [ET] cut off of =4.5 mm) and the WID™-qEC test. Sensitivity and specificity including 95% confidence intervals will be calculated, as well as the relevant positive predictive value (PPV) and negative predictive value (NPV). The ultrasound assessment as well as the Pipelle biopsy and WID™-qEC sample collection will be performed when the patient initially presents to the hospital. If hysteroscopy/endometrial biopsy and/or a hysterectomy is required, this will usually be carried out 1-4 weeks after the initial assessment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To assess the number of procedures required in WID™-qEC true-positive and false-negative patients to reach a histological diagnosis, measured using ultrasound +/- Pipelle biopsy at initial presentation, and hysteroscopy/endometrial biopsy and/or hysterectomy 1-4 weeks later, respectively. 2. Stage, histology and grade of disease at diagnosis and relation to WID™-qEC and TVUS findings, measured using surgical staging of the hysterectomy specimen after a hysterectomy has been performed. 3. Rates of inconclusive results, measured using the number of diagnostic procedures carried out (ultrasound, Pipelle biopsy, hysteroscopy/endometrial biopsy, hysterectomy) throughout the patient’s journey to assess the cause of abnormal vaginal bleeding. 4. Performance of the WID™-qCIN test – a test for detecting cervical cancer measured using colposcopy and cervical biopsies at the initial presentation or once referred for colposcopy assessment. | — |
Countries
England, United Kingdom
Contacts
Public ContactDan Reisel
Outcome results
None listed