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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Andre Nazac, 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.


Condition or disease Intervention/treatment Phase
Endometrial Cancer Procedure: Blind biopsy with a pipette Procedure: Targeted biopsy using hysteroscopy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Histological result [ Time Frame: 6 months ]
    Histological result (histological type and grading if cancer is diagnosed, according to the FIGO 2009 classification).



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03115593


Contacts
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Contact: André Nazac, MD 32 2 4772660 Andre.NAZAC@chu-brugmann.be

Locations
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Belgium
CHU Brugmann
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    fbuxant@his-izz.be   
Principal Investigator: Frédéric Buxant         
CHR Citadelle
Liege, Belgium, 4000
Contact: Laurent de Landsheere, MD    00 32 4 321 65 15    ldelandsheere@chu.ulg.ac.be   
Principal Investigator: Laurent de Landsheere, MD         
France
Hôpital Bicêtre
Le Kremlin Bicêtre, France, 94275
Contact: Hervé Fernandez, MD    01-45-21-77-01    herve.fernandez@bct.aphp.fr   
Principal Investigator: Hervé Fernandez, MD         
Sponsors and Collaborators
Brugmann University Hospital
Investigators
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Principal Investigator: André Nazac, MD CHU Brugmann
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Responsible Party: Andre Nazac, Head of clinic, Brugmann University Hospital
ClinicalTrials.gov Identifier: NCT03115593    
Other Study ID Numbers: CHUB-Hystocor
First Posted: April 14, 2017    Key Record Dates
Last Update Posted: July 12, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Andre Nazac, Brugmann University Hospital:
hysteroscopy
pipette
biopsy
endometrial cancer
Additional relevant MeSH terms:
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Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female