BiopsyHYSTEROBIONCT04519554
Hysteroscopic Guided Endometrial Sampling: Prospective Comparison Between 5Fr and 7Fr Biopsy Forceps (HYSTEROBIO)
A study testing Endometrial sampling in people with Biopsy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Indication for hysteroscopic guided biopsy compared to blind biopsy have been little evaluated. However, this kind of biopsy is usually performed in many centre. They allow exploration of uterine cavity but also to perform guided biopsies on the most suspicious area. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Biopsy
- What is being tested?
- Endometrial sampling
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteFrance
- Study dates
- 20 Sep 2020to 20 Dec 2021
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Woman over 18 year-old with abnormal uterine bleeding (or endometrium thickness over 10mm) and risk factors of endometrial carcinoma, or endometrium thickness over 5mm in a menopausal woman or abnormal uterine bleeding after 45 years old.
- Woman who speak and understand french
- Woman who give her written informed consent
- Woman covered by french medical insurance
Who cannot join
- • Pregnant or breastfeeding patient
- Patient under guardianship, curators or safeguard of justice.
- Patient participating in another ongoing study.
Trial locations and contacts
1 site in 1 country.
About this study
Indication for hysteroscopic guided biopsy compared to blind biopsy have been little evaluated. However, this kind of biopsy is usually performed in many centre. They allow exploration of uterine cavity but also to perform guided biopsies on the most suspicious area. However, with 5Fr forceps, biopsy are often too small to conclude.
Read the detailed description
Blind biopsies using Novak or Cormier cannula had limits. Demirkiran et al conclude on 673 women that histology was similar between biopsies and hysterectomy in only 67% of cases. Others studies conclude thatit is difficult to conclude about focal disease with blind biopsies.
A study compared blind biopsies to biopsy performed under hysteroscopic guidance in women using Tamoxifene and conclude that guided biopsies were more specific (80% versus 68.9%) and a better positive predictive value (68.9% versus 43.7%) for all kind of endometrial pathologies
- Conditions
- Biopsy
- Being tested
- Endometrial sampling
- Keywords
- endometrial sampling hysteroscopy, postmenopausal bleeding, endometrial carcinoma
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endometrial samplingDevice
Endometrial sampling with 2 different forceps
| Study group | Role | What they receive |
|---|---|---|
| 5FR + 7FR | Other | Each woman is its own control and had biopsies with the 2 size of forceps. In this group first with 5FR then 7 FR Receives: Device: Endometrial sampling |
| 7FR + 5FR | Other | Each woman is its own control and had biopsies with the 2 size of forceps. In this group first with 7FR then 5FR Receives: Device: Endometrial sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate ability to give a pathologic conclusion after 5Fr and 7Fr forceps biopsies
Evaluated by the number of cases on witch the biopsy allowed to conclude
Measured: During the pathologist's analysis
Secondary outcomes (3)
To compare histologic conclusions after 5 and 7Fr biopsies
Evaluated by Importance of collapse artifacts
Measured: During the pathologist's analysis
To compare rate of ability to obtain pathologic conclusion on the sample after 5Fr and 7Fr forceps in endometrial carcinoma
The number of endometrial malignancies diagnosed histologically with either forceps
Measured: During the pathologist's analysis
To evaluate the rate of hysteroscopic failure due to cervical stenosis
The number of cases where hysteroscopy was not possible
Measured: During the pathologist's analysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2020
- Study start20 Sep 2020 (estimated)
- Primary completion20 Dec 2021 (estimated)
- Study completion20 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BiopsyStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Perine CAPMAS, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04519554
- Sponsor's protocol ID
- APHP200243
- Other IDs
- 2017-A00621-52
- Acronym
- HYSTEROBIO
- Status last verified
- Aug 2020
- First submitted
- 17 Aug 2020
- Last updated
- 1 Sep 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 1 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hysteroscopic Guided Endometrial Sampling: Prospective Comparison Between 5Fr and 7Fr Biopsy Forceps (HYSTEROBIO)
- ClinicalTrials.gov ID
- NCT04519554
- Acronym / sponsor ID
- HYSTEROBIO / APHP200243
- Conditions
- Biopsy
- Keywords
- endometrial sampling hysteroscopy, postmenopausal bleeding, endometrial carcinoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 20 Sep 2020 (estimated)
- Primary completion
- 20 Dec 2021 (estimated)
- Study completion
- 20 Dec 2021 (estimated)
- First posted
- 19 Aug 2020 (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.
Indication for hysteroscopic guided biopsy compared to blind biopsy have been little evaluated. However, this kind of biopsy is usually performed in many centre. They allow exploration of uterine cavity but also to perform guided biopsies on the most suspicious area. However, with 5Fr forceps, biopsy are often too small to conclude.
Detailed description
Blind biopsies using Novak or Cormier cannula had limits. Demirkiran et al conclude on 673 women that histology was similar between biopsies and hysterectomy in only 67% of cases. Others studies conclude thatit is difficult to conclude about focal disease with blind biopsies.
A study compared blind biopsies to biopsy performed under hysteroscopic guidance in women using Tamoxifene and conclude that guided biopsies were more specific (80% versus 68.9%) and a better positive predictive value (68.9% versus 43.7%) for all kind of endometrial pathologies
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 5FR + 7FR | Other | Device: Endometrial samplingEach woman is its own control and had biopsies with the 2 size of forceps. In this group first with 5FR then 7 FR |
| 7FR + 5FR | Other | Device: Endometrial samplingEach woman is its own control and had biopsies with the 2 size of forceps. In this group first with 7FR then 5FR |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- • Woman over 18 year-old with abnormal uterine bleeding (or endometrium thickness over 10mm) and risk factors of endometrial carcinoma, or endometrium thickness over 5mm in a menopausal woman or abnormal uterine bleeding after 45 years old.
Key exclusion criteria (3 listed)
- • Pregnant or breastfeeding patient
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 |
|---|---|---|
| Endometrial samplingEndometrial sampling with 2 different forceps | Device | 5FR + 7FR, 7FR + 5FR |
Primary outcome
To evaluate ability to give a pathologic conclusion after 5Fr and 7Fr forceps biopsies
Time frame: During the pathologist's analysis
Evaluated by the number of cases on witch the biopsy allowed to conclude
3 secondary outcomes
To compare histologic conclusions after 5 and 7Fr biopsies
Time frame: During the pathologist's analysis
To compare rate of ability to obtain pathologic conclusion on the sample after 5Fr and 7Fr forceps in endometrial carcinoma
Time frame: During the pathologist's analysis
To evaluate the rate of hysteroscopic failure due to cervical stenosis
Time frame: During the pathologist's analysis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 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.
Perine CAPMAS principal investigator
APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endometrial sampling in people with Biopsy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 1 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Perinne CAPMAS (+33(0)145217701, perinne.capmas@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate ability to give a pathologic conclusion after 5Fr and 7Fr forceps biopsies (time frame: During the pathologist's analysis). 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 1 Sep 2020.