NCT03115593

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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2018

Geographic Reach
2 countries

4 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 11, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 14, 2017

Completed
1.2 years until next milestone

Study Start

First participant enrolled

July 10, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2020

Completed
Last Updated

August 7, 2020

Status Verified

August 1, 2020

Enrollment Period

1.6 years

First QC Date

April 11, 2017

Last Update Submit

August 6, 2020

Conditions

Endometrial Cancer

Keywords

hysteroscopypipettebiopsyendometrial cancer

Outcome Measures

Primary Outcomes (1)

  • Histological result

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

    6 months

Study Arms (1)

postmenopausal patients with metrorrhagia

EXPERIMENTAL

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 pipetteProcedure: Targeted biopsy using hysteroscopy

Interventions

Blind biopsy with a pipettePROCEDURE

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.

postmenopausal patients with metrorrhagia
Targeted biopsy using hysteroscopyPROCEDURE

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.

postmenopausal patients with metrorrhagia

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

CHU Brugmann

Brussels, 1020, Belgium

Location

Hôpitaux Iris Sud - Site Ixelles

Brussels, 1050, Belgium

Location

CHR Citadelle

Liège, 4000, Belgium

Location

Hôpital Bicêtre

Le Kremlin-Bicêtre, 94275, France

Location

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • André Nazac, MD

    CHU Brugmann

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of clinic

Study Record Dates

First Submitted

April 11, 2017

First Posted

April 14, 2017

Study Start

July 10, 2018

Primary Completion

March 2, 2020

Study Completion

March 2, 2020

Last Updated

August 7, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)BE(3)