Validation study for the WID-qEC test in women undergoing hysterectomy: A diagnostic accuracy study
| ISRCTN | ISRCTN12164818 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12164818 |
- Submission date
- 29/01/2025
- Registration date
- 10/02/2025
- Last edited
- 10/03/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
The POPCORN study will analyze the performance of the WID-qEC diagnostic test for endometrial carcinoma.
Who can participate?
All women undergoing hysterectomy at the University Hospital in Bern, Switzerland
What does the study involve?
The participants will be asked to undergo a WID-qEC test before their operation during their visit where a vaginal examination is planned. After that, the planned hysterectomy will be performed, no matter the underlying disease. The WID-qEC test results will then be compared to the histology results of the hysterectomy to evaluate the accuracy of the test and try to identify confounding factors.
What are the possible benefits and risks of participating?
There are no foreseen possible benefits from participation. The risks are slight bleeding at the site of sampling in the vagina, although this is very rare.
Where is the study run from?
Inselspital Bern, Switzerland
When is the study starting and how long is it expected to run for?
January 2025 to January 2026
Who is funding the study?
The labor team w in St. Gallen, Switzerland, provides the tests without cost to patients
Who is the main contact?
Franziska Siegenthaler MD, franziska.siegenthaler@insel.ch
Contact information
Public, Scientific, Principal Investigator
Inselspital - University Hospital of Bern
Friedbühlstrasse 19
Bern
3011
Switzerland
| Phone | +41 632 10 10 |
|---|---|
| franziska.siegenthaler@insel.ch |
Study information
| Study design | Non-randomized diagnostic accuracy study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Prospective diagnostic accuracy study |
| Study setting(s) | Hospital, Laboratory |
| Study type | Diagnostic, Safety |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | PrOsPective observational COhoRt study on the performaNce of the WID-qEC test in patients undergoing hysterectomy |
| Study acronym | Popcorn |
| Study objectives | This study evaluates the sensitivity and specificity of the WID-qEC test to evaluate its performance and identify factors that influence its performance. |
| Ethics approval(s) |
Approved 29/01/2025, Cantonal Ethics Committee for Research Bern (Rathausgasse 1, Bern, 3011, Switzerland; +41 31 633 70 70; mario.amacker@be.ch), ref: 2024-02365 |
| Health condition(s) or problem(s) studied | Performance of the WID-qEC test to accurately detect endometrium carcinoma in women who undergo planned hysterectomy |
| Intervention | 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. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | WID-qEC test |
| Primary outcome measure | 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 outcome measures | 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. |
| Overall study start date | 01/01/2025 |
| Completion date | 31/01/2026 |
Eligibility
| Participant type(s) | Population |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 350 |
| Key inclusion criteria | Undergoing total hysterectomy at University Hospital Bern, CH |
| Key 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 |
| Date of first enrolment | 03/03/2025 |
| Date of final enrolment | 31/01/2026 |
Locations
Countries of recruitment
- Switzerland
Study participating centre
Bern
3011
Switzerland
Sponsor information
Hospital/treatment centre
Inselspital
Friedbühlstrasse 19
Bern
3011
Switzerland
| Phone | +41 31 632 10 10 |
|---|---|
| chefarztsekretariat.gynaeokologie@insel.ch | |
| Website | https://www.insel.ch/de/ |
"ROR" |
https://ror.org/01q9sj412 |
Funders
Funder type
Industry
No information available
No information available
Results and Publications
| Intention to publish date | 01/02/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date. |
Editorial Notes
10/03/2025: The recruitment start date was changed from 17/02/2025 to 03/03/2025.
12/02/2025: The recruitment start date was changed from 01/02/2025 to 17/02/2025.
31/01/2025: Study's existence confirmed by the Cantonal Ethics Committee for Research Bern.
