Endometrial CancerNCT03115593
Compare the Performance of Targeted Biopsy Versus Aspiration Biopsy With a Pipette for the Diagnosis of Endometrial Cancer
A study testing Blind biopsy with a pipette and Targeted biopsy using hysteroscopy in people with Endometrial Cancer, run by Brugmann University Hospital at 4 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- Blind biopsy with a pipette and Targeted biopsy using hysteroscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 10 Jul 2018to 2 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- postmenopausal patient.
- patient with postmenopausal metrorrhagia and endometrial hypertrophy defined by an endometrium ticker than 3 mm (ultrasound result)
Who cannot join
- patients undergoing hormone replacement therapy for menopause (THM). This treatment may be the cause of benign bleeding in post menopause.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Belgium3 sites
CHU Brugmann
Brussels, 1020
Hôpitaux Iris Sud - Site Ixelles
Brussels, 1050
CHR Citadelle
Liège, 4000
About this study
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.
Read more
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.
- Conditions
- Endometrial Cancer
- Being tested
- Blind biopsy with a pipette, Targeted biopsy using hysteroscopy
- Keywords
- hysteroscopy, pipette, biopsy, endometrial cancer
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blind biopsy with a pipetteProcedure or surgery
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.
Targeted biopsy using hysteroscopyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Blind biopsy with a pipette; Procedure: Targeted biopsy using hysteroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histological result
Histological result (histological type and grading if cancer is diagnosed, according to the FIGO 2009 classification).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study start10 Jul 2018
- Primary completion2 Mar 2020
- Study completion2 Mar 2020
Why it stopped: Lack of human ressources
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brugmann University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andre Nazac, Brugmann University Hospital
- Investigators
- André Nazac, MD, Principal investigator, CHU Brugmann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03115593
- Sponsor's protocol ID
- CHUB-Hystocor
- Status last verified
- Aug 2020
- First submitted
- 11 Apr 2017
- Last updated
- 7 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compare the Performance of Targeted Biopsy Versus Aspiration Biopsy With a Pipette for the Diagnosis of Endometrial Cancer
- ClinicalTrials.gov ID
- NCT03115593
- Acronym / sponsor ID
- CHUB-Hystocor
- Conditions
- Endometrial Cancer
- Keywords
- hysteroscopy, pipette, biopsy, endometrial cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of human ressources
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Brugmann University HospitalUniversity, hospital or other
- Study start
- 10 Jul 2018 (actual)
- Primary completion
- 2 Mar 2020 (actual)
- Study completion
- 2 Mar 2020 (actual)
- First posted
- 14 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| postmenopausal patients with metrorrhagia | Experimental | Procedure: Blind biopsy with a pipette, Procedure: Targeted biopsy using hysteroscopyPostmenopausal 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- postmenopausal patient.
- patient with postmenopausal metrorrhagia and endometrial hypertrophy defined by an endometrium ticker than 3 mm (ultrasound result)
Key exclusion criteria (1 listed)
- patients undergoing hormone replacement therapy for menopause (THM). This treatment may be the cause of benign bleeding in post menopause.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blind biopsy with a pipettePatients 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 or surgery | postmenopausal patients with metrorrhagia |
| Targeted biopsy using hysteroscopyDuring 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. | Procedure or surgery | postmenopausal patients with metrorrhagia |
Primary outcome
Histological result
Time frame: 6 months
Histological result (histological type and grading if cancer is diagnosed, according to the FIGO 2009 classification).
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
André Nazac, MD principal investigator
CHU Brugmann
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blind biopsy with a pipette and Targeted biopsy using hysteroscopy in people with Endometrial Cancer, run by Brugmann University Hospital at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Belgium, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Histological result (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2020.