ENDS (ENDometriosis & FuSobacterium) Unveiling the Contribution of Fusobacterium Infection to the Development of Endometriosis
NCT ID: NCT06368596
Last Updated: 2024-04-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
845 participants
INTERVENTIONAL
2024-04-30
2025-10-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Study arm
Patients in reproductive age, who will undergo elective surgery for endometriosis.
Fusobacterium detection
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.
Control arm
Women in reproductive age, without endometriosis, as control group for secondary objective 1 and 2.
Fusobacterium detection
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.
Interventions
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Fusobacterium detection
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.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* Menopause
* antibiotic therapy in the 30 days before samples collection (including vaginal and cervical swab).
18 Years
FEMALE
No
Sponsors
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IRCCS Sacro Cuore Don Calabria di Negrar
OTHER
Responsible Party
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Locations
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IRCCS Sacro Cuore Don Calabria di Negrar
Negrar, Verona, Italy
Countries
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Central Contacts
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Facility Contacts
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Role: backup
Other Identifiers
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2024-04
Identifier Type: -
Identifier Source: org_study_id
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