Compare the Performance of Targeted Biopsy Versus Aspiration Biopsy With a Pipette for the Diagnosis of Endometrial Cancer
|ClinicalTrials.gov Identifier: NCT03115593|
Recruitment Status : Unknown
Verified July 2018 by Andre Nazac, Brugmann University Hospital.
Recruitment status was: Not yet recruiting
First Posted : April 14, 2017
Last Update Posted : July 12, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Endometrial Cancer||Procedure: Blind biopsy with a pipette Procedure: Targeted biopsy using hysteroscopy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||360 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Compare the Performance of Targeted Biopsy Versus Aspiration Biopsy With a Pipette for the Diagnosis of Endometrial Cancer|
|Estimated Study Start Date :||August 2018|
|Estimated Primary Completion Date :||March 2020|
|Estimated Study Completion Date :||March 2020|
Experimental: postmenopausal patients with metrorrhagia
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.
Procedure: Blind biopsy with a pipette
Patients willing to participate to the study will benefit from a double biopsy. The first biopsy will be a blind biopsy performed by aspiration with a Cornier pipette.
Procedure: Targeted biopsy using hysteroscopy
During the same consultation, patients will benefit from a diagnostic hysteroscopy with vaginoscopy and saline (allowing a wash of the debris caused by the pipette biopsy), using a rigid hysteroscope of 4.3 mm equipped with an operator channel allowing the passage of a biopsy tong.
- Histological result [ Time Frame: 6 months ]Histological result (histological type and grading if cancer is diagnosed, according to the FIGO 2009 classification).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03115593
|Contact: André Nazac, MD||32 2 4772660||Andre.NAZAC@chu-brugmann.be|
|Brussels, Belgium, 1020|
|Contact: André Nazac, MD 32 2 4772660 Andre.NAZAC@chu-brugmann.be|
|Principal Investigator: André Nazac, MD|
|Hôpitaux Iris Sud - Site Ixelles|
|Brussels, Belgium, 1050|
|Contact: Frédéric Buxant, MD 00 32 2 739 85 85 firstname.lastname@example.org|
|Principal Investigator: Frédéric Buxant|
|Liege, Belgium, 4000|
|Contact: Laurent de Landsheere, MD 00 32 4 321 65 15 email@example.com|
|Principal Investigator: Laurent de Landsheere, MD|
|Le Kremlin Bicêtre, France, 94275|
|Contact: Hervé Fernandez, MD 01-45-21-77-01 firstname.lastname@example.org|
|Principal Investigator: Hervé Fernandez, MD|
|Principal Investigator:||André Nazac, MD||CHU Brugmann|