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ENDS (ENDometriosis & FuSobacterium) Unveiling the Contribution of Fusobacterium Infection to the Development of Endometriosis
Sponsor: IRCCS Sacro Cuore Don Calabria di Negrar
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. 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.
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
845
Start Date
2024-04
Completion Date
2025-10
Last Updated
2024-04-16
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (1)
IRCCS Sacro Cuore Don Calabria di Negrar
Negrar, Verona, Italy