EndometriosisENDSNCT06368596
ENDS (ENDometriosis & FuSobacterium) Unveiling the Contribution of Fusobacterium Infection to the Development of Endometriosis
A study testing Fusobacterium detection in people with Endometriosis, run by IRCCS Sacro Cuore Don Calabria di Negrar at 1 site in Italy.
Trial summary
This will be a clinical interventional longitudinal study, without pharmacological intervention/device evaluation. A control group would however be recruited for secondary objective 1 and 2. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- Fusobacterium detection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 845 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2024to Oct 2025
- 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
- Age ≥ 18 years;
- endometriosis with clinical indication for either hysteroscopy or hysterectomy;
- signed informed consent to study participation and to personal data's treatment.
- need of elective gynecological surgery for causes other than endometriosis and malignancies;
- indication for hysteroscopy with endometrial biopsy;
- signed informed consent to study participation and to personal data's treatment.
Who cannot join
- lack of signed informed consent;
- Menopause
- antibiotic therapy in the 30 days before samples collection (including vaginal and cervical swab).
Trial locations and contacts
1 site in 1 country.
Italy1 site
IRCCS Sacro Cuore Don Calabria di Negrar
Negrar, Verona
Marcello Ceccaroni, Doctor, marcello.ceccaroni@sacrocuore.it
0456013111
About this study
This will be a clinical interventional longitudinal study, without pharmacological intervention/device evaluation.
A control group would however be recruited for secondary objective 1 and 2.
The study is classified as interventional, as Fusobacterium detection is not part of the routine management of these patients; from the patients' point of view, participation in the study will involve the execution of additional vaginal and cervical swabs as additional procedure, while the endometrial biopsy will not represent an additional examination, as the study will include only patients for whom this examination is expected as per normal clinical practice.
- Conditions
- Endometriosis
- Being tested
- Fusobacterium detection
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fusobacterium detectionDiagnostic test
One vaginal and one cervical swab will be collected from participants (both cases and controls) before surgery.
During surgical intervention, routine biopsies of the endometriotic tissue will be done for all endometriosis types; further, small biopsies of apparently healthy endometrial tissue and of healthy peritoneum will be done, as per routine procedure.
In the control group routine biopsies needed for the specific condition and small biopsies of endometrial tissue will be carried out.
During these routine biopsies, a small additional quantity of tissue will be taken, which will be analyzed for the search for Fusobacterium.
| Study group | Role | What they receive |
|---|---|---|
| Study arm | Other | Patients in reproductive age, who will undergo elective surgery for endometriosis. Receives: Diagnostic Test: Fusobacterium detection |
| Control arm | Other | Women in reproductive age, without endometriosis, as control group for secondary objective 1 and 2. Receives: Diagnostic Test: Fusobacterium detection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fusobacterium sp presence (Y/N) in endometrial biopsy in women with endometriosis
Measured: At surgical intervention
Secondary outcomes (6)
Fusobacterium presence (Y/N) in endometrial biopsy in women without endometriosis
Measured: At surgical intervention
Fusobacterium presence (Y/N) in vaginal and cervical swab in all women enrolled
Measured: At preoperative visit
Fusobacterium presence (Y/N) in endometrial biopsy in women with and without PID complicating endometriosis .
Measured: At surgical intervention
Fusobacterium presence (Y/N) in biopsies of endometrial tissue involving different sites (superficial lesions, deep endometriosis, ovarian endometrioma), if present
Measured: At surgical intervention
Fusobacterium presence (Y/N) in endometrial biopsy in women with and without infertility associated to endometriosis
Measured: At surgical intervention
Fusobacterium presence (Y/N) in endometrial biopsy in women with and without hysteroscopic signs of chronic endometritis in patients with and without endometriosis
Measured: At surgical intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study startApr 2024 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 845 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Sacro Cuore Don Calabria di Negrar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06368596
- Sponsor's protocol ID
- 2024-04
- Acronym
- ENDS
- Status last verified
- Apr 2024
- First submitted
- 11 Apr 2024
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ENDS (ENDometriosis & FuSobacterium) Unveiling the Contribution of Fusobacterium Infection to the Development of Endometriosis
- ClinicalTrials.gov ID
- NCT06368596
- Acronym / sponsor ID
- ENDS / 2024-04
- Conditions
- Endometriosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 845 participants (estimated)
- Lead sponsor
- IRCCS Sacro Cuore Don Calabria di NegrarUniversity, hospital or other
- Study start
- Apr 2024 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 16 Apr 2024 (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.
This will be a clinical interventional longitudinal study, without pharmacological intervention/device evaluation.
A control group would however be recruited for secondary objective 1 and 2.
The study is classified as interventional, as Fusobacterium detection is not part of the routine management of these patients; from the patients' point of view, participation in the study will involve the execution of additional vaginal and cervical swabs as additional procedure, while the endometrial biopsy will not represent an additional examination, as the study will include only patients for whom this examination is expected as per normal clinical practice.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study arm | Other | Diagnostic Test: Fusobacterium detectionPatients in reproductive age, who will undergo elective surgery for endometriosis. |
| Control arm | Other | Diagnostic Test: Fusobacterium detectionWomen in reproductive age, without endometriosis, as control group for secondary objective 1 and 2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years;
- endometriosis with clinical indication for either hysteroscopy or hysterectomy;
- signed informed consent to study participation and to personal data's treatment.
- need of elective gynecological surgery for causes other than endometriosis and malignancies;
- indication for hysteroscopy with endometrial biopsy;
Key exclusion criteria (3 listed)
- lack of signed informed consent;
- Menopause
- antibiotic therapy in the 30 days before samples collection (including vaginal and cervical swab).
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 |
|---|---|---|
| Fusobacterium detectionOne vaginal and one cervical swab will be collected from participants (both cases and controls) before surgery. During surgical intervention, routine biopsies of the endometriotic tissue will be done for all endometriosis types; further, small biopsies of apparently healthy endometrial tissue and of healthy peritoneum will be done, as per routine procedure. In the control group routine biopsies needed for the specific condition and small biopsies of endometrial tissue will be carried out. During these routine biopsies, a small additional quantity of tissue will be taken, which will be analyzed for the search for Fusobacterium. | Diagnostic test | Control arm, Study arm |
Primary outcome
Fusobacterium sp presence (Y/N) in endometrial biopsy in women with endometriosis
Time frame: At surgical intervention
6 secondary outcomes
Fusobacterium presence (Y/N) in endometrial biopsy in women without endometriosis
Time frame: At surgical intervention
Fusobacterium presence (Y/N) in vaginal and cervical swab in all women enrolled
Time frame: At preoperative visit
Fusobacterium presence (Y/N) in endometrial biopsy in women with and without PID complicating endometriosis .
Time frame: At surgical intervention
Fusobacterium presence (Y/N) in biopsies of endometrial tissue involving different sites (superficial lesions, deep endometriosis, ovarian endometrioma), if present
Time frame: At surgical intervention
Fusobacterium presence (Y/N) in endometrial biopsy in women with and without infertility associated to endometriosis
Time frame: At surgical intervention
Fusobacterium presence (Y/N) in endometrial biopsy in women with and without hysteroscopic signs of chronic endometritis in patients with and without endometriosis
Time frame: At surgical intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fusobacterium detection in people with Endometriosis, run by IRCCS Sacro Cuore Don Calabria di Negrar at 1 site in Italy.
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 6 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 16 Apr 2024. 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 Italy. 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 Elvia Malo (+390456014854, ricerca.clinica@sacrocuore.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fusobacterium sp presence (Y/N) in endometrial biopsy in women with endometriosis (time frame: At surgical intervention). 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 16 Apr 2024.