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Weefselonderzoek van het baarmoederslijmvlies

Endometrial Intraepithelial Neoplasia (EIN) in minimally invasive endometrial biopsies

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON26300
Enrollment
500
Registered
2019-03-18
Start date
2016-02-02
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Endometrial cancer, endometrial hyperplasia and endometrial intraepithelial Neoplasia (EIN)

Interventions

Women with a planned, standard samplig procedure are recruited. No additional interventions are done for the purpose of the study.

Sponsors

Erasmus MC
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients, aged 40 years and older, visiting the outpatient clinic with any indication for endometrial biopsy following the Dutch guidelines and common practice. At the distinction of the gynaecologist samples are either obtained by an office sampling device, or by hysteroscopy.

Exclusion criteria

Exclusion criteria: Age < 40 Not able to give informed consent

Design outcomes

Primary

MeasureTime frame
-What is the accuracy of the EIN diagnosed in an office setting (sampling devices and hysteroscopic biopsies)?

Secondary

MeasureTime frame
- What is the risk of a malignancy after EIN in samples obtained in an office setting (office endometrial sampling as well as hysteroscopy)? - Do samples obtained in an office setting (office endometrial sampling as well as hysteroscopy) contains sufficient material to diagnose EIN? - How do EIN and hyperplasia correlate in samples obtained in an office setting (office endometrial sampling as well as hysteroscopy)? - Do gynaecologist adhere to the current Dutch guideline postmenopausal bleeding (11.2015)

Contacts

Public ContactLena van Doorn

ErasmusMC Cancer Institute

h.vandoorn@erasmusmc.nl+31630778464

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)