Compare the Performance of Targeted Biopsy Versus Aspiration Biopsy With a Pipette for the Diagnosis of Endometrial Cancer

Not Applicable

Withdrawn

• Conditions: Endometrial Cancer
• Interventions: Procedure: Blind biopsy with a pipette; Procedure: Targeted biopsy using hysteroscopy

• Registration Number: NCT03115593
• Lead Sponsor: Brugmann University Hospital

Brief Summary

Endometrial cancer is the most common pelvic gynecological cancer in so-called developed countries, with 320,000 new cases annually, including more than 1,500 in Belgium. It preferentially affects postmenopausal women. Overall survival at 5 years is 76% but is 95% for early forms, which represent more than 70% of diagnoses. The main risk factors are obesity, diabetes and tamoxifen intake for breast cancer, which explains the increasing incidence. Half a million new annual cases are expected in 2035.

The main symptom is postmenopausal metrorrhagia.Among these women, the prevalence of the disease is estimated between 10 and 15%. Currently the recommendations are to make an evaluation by endovaginal ultrasound followed by an endometrial biopsy. The histological type is the main predictor of the severity of the disease and acts as guideline for the treatment.It is therefore essential to have precise biopsy results before starting therapeutic management.

The most widely used technique is the blind biopsy by aspiration using a pipette because it is inexpensive, easy, without any specific equipment. However, recent studies showed that this technique has a poor sensitivity in the target population of postmenopausal women. Other studies have shown that targeted biopsies under hysteroscopic control could have a much higher sensitivity.

The main objective of this study is thus to compare the performance of the targeted biopsy under hysteroscopy to the performance of the biopsy by aspiration with a pipette, for the diagnosis of endometrial cancer.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-04-11
• Study First Submitted QC: 2017-04-11
• Study First Posted: 2017-04-14
• Study Start: 2018-07-10
• Primary Completion: 2020-03-02
• Study Completion: 2020-03-02
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-06
• Last Update Posted: 2020-08-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

• postmenopausal patient.
• patient with postmenopausal metrorrhagia and endometrial hypertrophy defined by an endometrium ticker than 3 mm (ultrasound result)

Exclusion Criteria

• patients undergoing hormone replacement therapy for menopause (THM). This treatment may be the cause of benign bleeding in post menopause.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
postmenopausal patients with metrorrhagia	Blind biopsy with a pipette	Postmenopausal patients with metrorrhagia and endometrial hypertrophy defined by an endometrium ticker than 3 mm (ultrasound result). The threshold choice of 3 mm was chosen according to a recent review of the literature to limit the risk of false negatives for cancer.
postmenopausal patients with metrorrhagia	Targeted biopsy using hysteroscopy	Postmenopausal patients with metrorrhagia and endometrial hypertrophy defined by an endometrium ticker than 3 mm (ultrasound result). The threshold choice of 3 mm was chosen according to a recent review of the literature to limit the risk of false negatives for cancer.

Primary Outcome Measures

Name	Time	Method
Histological result	6 months	Histological result (histological type and grading if cancer is diagnosed, according to the FIGO 2009 classification).

Trial Locations

Locations (4)

Hôpital Bicêtre; 🇫🇷 Le Kremlin Bicêtre, France

Hôpitaux Iris Sud - Site Ixelles; 🇧🇪 Brussels, Belgium

CHR Citadelle; 🇧🇪 Liege, Belgium

CHU Brugmann; 🇧🇪 Brussels, Belgium