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
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.
Study Type
Interventional
Primary Outcome
Histological result
Condition
Endometrial Cancer
Intervention
Blind biopsy with a pipette
Study Arms / Comparison Groups
postmenopausal patients with metrorrhagia
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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
0
Start Date
July 10, 2018
Completion Date
March 2, 2020
Primary Completion Date
March 2, 2020
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.
Gender
Female
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
André Nazac, MD, ,
Location Countries
Belgium
Location Countries
Belgium
Administrative Informations
NCT ID
NCT03115593
Organization ID
CHUB-Hystocor
Responsible Party
Principal Investigator
Study Sponsor
Brugmann University Hospital
Study Sponsor
André Nazac, MD, Principal Investigator, CHU Brugmann
Verification Date
August 2020