Compare the Performance of Targeted Biopsy Versus Aspiration Biopsy With a Pipette for the Diagnosis of Endometrial Cancer
Primary Purpose
Endometrial Cancer
Status
Withdrawn
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Blind biopsy with a pipette
Targeted biopsy using hysteroscopy
Sponsored by
About this trial
This is an interventional diagnostic trial for Endometrial Cancer focused on measuring hysteroscopy, pipette, biopsy, endometrial cancer
Eligibility 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.
Sites / Locations
- CHU Brugmann
- Hôpitaux Iris Sud - Site Ixelles
- CHR Citadelle
- Hôpital Bicêtre
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
postmenopausal patients with metrorrhagia
Arm Description
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.
Outcomes
Primary Outcome Measures
Histological result
Histological result (histological type and grading if cancer is diagnosed, according to the FIGO 2009 classification).
Secondary Outcome Measures
Full Information
NCT ID
NCT03115593
First Posted
April 11, 2017
Last Updated
August 6, 2020
Sponsor
Brugmann University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03115593
Brief Title
Compare the Performance of Targeted Biopsy Versus Aspiration Biopsy With a Pipette for the Diagnosis of Endometrial Cancer
Official Title
Compare the Performance of Targeted Biopsy Versus Aspiration Biopsy With a Pipette for the Diagnosis of Endometrial Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of human ressources
Study Start Date
July 10, 2018 (Actual)
Primary Completion Date
March 2, 2020 (Actual)
Study Completion Date
March 2, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brugmann University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Cancer
Keywords
hysteroscopy, pipette, biopsy, endometrial cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
postmenopausal patients with metrorrhagia
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Blind biopsy with a pipette
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Targeted biopsy using hysteroscopy
Intervention Description
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 Measure Information:
Title
Histological result
Description
Histological result (histological type and grading if cancer is diagnosed, according to the FIGO 2009 classification).
Time Frame
6 months
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
André Nazac, MD
Organizational Affiliation
CHU Brugmann
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Brugmann
City
Brussels
ZIP/Postal Code
1020
Country
Belgium
Facility Name
Hôpitaux Iris Sud - Site Ixelles
City
Brussels
ZIP/Postal Code
1050
Country
Belgium
Facility Name
CHR Citadelle
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Hôpital Bicêtre
City
Le Kremlin Bicêtre
ZIP/Postal Code
94275
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Compare the Performance of Targeted Biopsy Versus Aspiration Biopsy With a Pipette for the Diagnosis of Endometrial Cancer
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