Validation study for the WID-qEC test in women undergoing hysterectomy: A diagnostic accuracy study

PrOsPective observational COhoRt study on the performaNce of the WID-qEC test in patients undergoing hysterectomy

Registry ID
ISRCTN12164818
Source registry
ISRCTN
Status
Recruiting
Study type
OBSERVATIONAL
Sponsor
University Hospital of Bern
Enrollment
350
Start date
2025-03-03
Completion date
2026-12-31
Last update
2026-08-17

Conditions

Summary

Performance of the WID-qEC test to accurately detect endometrium carcinoma in women who undergo planned hysterectomy

Detailed description

The WID-qEC test is used before the hysterectomy in a non-randomised allocation. The results of the WID-qEC test will be compared with the final histology to evaluate sensitivity and specificity. Patients are sampled consecutively when they have a planned total hysterectomy at University Hospital in Bern. There has been no Standard Test up till now, the nearest to fulfill this description is a transvaginal ultrasound. Therefore, the index Test (WID-qEC Test) is not compared to standard testing. The performance of the transvaginal ultrasound and the WID-qEC Test is mainly used when the symptom of postmenopausal bleeding occurs. However, the transvaginal ultrasound will not be replaced by the WID-qEC test. It is thought to be an additional diagnostic tool to prevent further interventional diagnostics such as a hysteroscopy which is mostly unnecessary (in case of non-malignant bleeding). There is no follow-up after the test has been taken.

Interventions

Inclusion criteria

Undergoing total hysterectomy at University Hospital Bern, CH

Exclusion criteria

1. Lack of capacity to provide written informed consent 2. Refusal to participate in the study 3. Presence of medical conditions contraindicating general anesthesia

Locations

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