Accuracy of a novel test in the early detection of endometrial cancer in African women presenting with abnormal uterine bleeding

Diagnostic accuracy of an epigenetic-based test in the early detection of endometrial cancer in African women presenting with abnormal uterine bleeding

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN18027281

Enrollment

200

Registered

2023-11-08

Start date

2023-06-01

Completion date

Unknown

Last updated

2026-02-09

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

Conditions

Early detection and diagnosis of endometrial cancer in African women. Cancer

Interventions

Methodology This research employs an observational cohort design to explore an enhanced method for detecting endometrial cancer. It aims to determine whether the addition of cervicovaginal smear sampl

Eligibility

Sex/Gender

Female

Age

40 Years to 90 Years

Inclusion criteria

Inclusion criteria: Women, aged 40 years and above, who present with abnormal vaginal bleeding

Exclusion criteria

Exclusion criteria: 1. Current pregnancy 2. History of hysterectomy 3. History of cervical or vulval cancer 4. Concurrent other malignancy

Design outcomes

Primary

Measure	Time frame
Diagnostic accuracy of the WID™-qEC test in detecting endometrial cancer in women with abnormal uterine bleeding. The WID™-qEC test assesses DNA methylation changes in specific gene regions by analyzing cervicovaginal smear samples collected from participants. This test identifies hypermethylation patterns associated with endometrial cancer development.	—

Secondary

Measure	Time frame
1. Transvaginal Ultrasonography (TVUS) Accuracy measured by assessing the accuracy of endometrial thickness measurement using TVUS after TVUS is conducted as part of the standard evaluation protocol 2. Endometrial Biopsy (EB) Diagnostic Reliability measured by evaluating the reliability of endometrial biopsy in providing accurate diagnostic information after endometrial biopsy is performed, following a positive TVUS result 3. Patient Experience measured by collecting feedback from participants about their comfort and experience during cervicovaginal smear sample collection 4. Comparative Diagnostic Performance measured by comparing the diagnostic accuracy of the WID™-qEC test with the standard evaluation protocol after completion of data analysis and comparison between the two diagnostic approaches	—

Measure

Time frame

1. Transvaginal Ultrasonography (TVUS) Accuracy measured by assessing the accuracy of endometrial thickness measurement using TVUS after TVUS is conducted as part of the standard evaluation protocol 2. Endometrial Biopsy (EB) Diagnostic Reliability measured by evaluating the reliability of endometrial biopsy in providing accurate diagnostic information after endometrial biopsy is performed, following a positive TVUS result 3. Patient Experience measured by collecting feedback from participants about their comfort and experience during cervicovaginal smear sample collection 4. Comparative Diagnostic Performance measured by comparing the diagnostic accuracy of the WID™-qEC test with the standard evaluation protocol after completion of data analysis and comparison between the two diagnostic approaches

—

Countries

Ghana

Contacts

Public ContactMartin Widschwendter

Martin.Widschwendter@uibk.ac.at+43 (0)676 872550406

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 15, 2026