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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN12164818

Enrollment

350

Registered

2025-02-10

Start date

2025-03-03

Completion date

Unknown

Last updated

2026-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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. Pat

Eligibility

Sex/Gender

Female

Age

18 Years to 100 Years

Inclusion criteria

Inclusion criteria: Undergoing total hysterectomy at University Hospital Bern, CH

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
The sensitivity and specificity of the WID-qEC test result measured using samples obtained from the cervicovaginal region immediately before the hysterectomy for the detection of endometrial/cervical cancers compared to a histology hysterectomy specimen	—

Secondary

Measure	Time frame
1. The underlying pathology of the ectocervix, cervical canal, endometrium and fallopian tube (and if also removed the ovary) in patients whose WID-qEC test (measured using histopathology of samples obtained from the cervicovaginal region immediately before the hysterectomy) is a false positive (i.e. WID-qEC test is positive in the absence of cancer in the hysterectomy/adnexal specimen). 2. The underlying pathology of the ectocervix, cervical canal and endometrium in patients whose WID-qEC test (measured using histopathology of samples obtained from the cervicovaginal region immediately before the hysterectomy) is a false negative (i.e. WID-qEC test is negative despite the presence of an invasive cancer in the cervix or the endometrial cavity). 3. To compare the level of the sum of the percentage of fully methylated reference (PMR) values of the WID-qEC test (using samples obtained from the cervicovaginal region immediately before the hysterectomy) with the immunohistochemical markers assessed in the cancerous endometrium (p53, MMR markers, Ki67) or non-cancer patients (Ki67 only) in the normal endometrium or the most advanced hyperplastic lesion.	—

Measure

Time frame

1. The underlying pathology of the ectocervix, cervical canal, endometrium and fallopian tube (and if also removed the ovary) in patients whose WID-qEC test (measured using histopathology of samples obtained from the cervicovaginal region immediately before the hysterectomy) is a false positive (i.e. WID-qEC test is positive in the absence of cancer in the hysterectomy/adnexal specimen). 2. The underlying pathology of the ectocervix, cervical canal and endometrium in patients whose WID-qEC test (measured using histopathology of samples obtained from the cervicovaginal region immediately before the hysterectomy) is a false negative (i.e. WID-qEC test is negative despite the presence of an invasive cancer in the cervix or the endometrial cavity). 3. To compare the level of the sum of the percentage of fully methylated reference (PMR) values of the WID-qEC test (using samples obtained from the cervicovaginal region immediately before the hysterectomy) with the immunohistochemical markers assessed in the cancerous endometrium (p53, MMR markers, Ki67) or non-cancer patients (Ki67 only) in the normal endometrium or the most advanced hyperplastic lesion.

—

Countries

Switzerland

Contacts

Public ContactFranziska Siegenthaler

franziska.siegenthaler@insel.ch+41 632 10 10

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 3, 2026