ENDS (ENDometriosis & FuSobacterium) Unveiling the Contribution of Fusobacterium Infection to the Development of Endometriosis (ENDS)

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 Overview

• Status: Not yet recruiting
• Conditions: Endometriosis
• Intervention / Treatment: Diagnostic test: Fusobacterium detection

• Study Type: Interventional
• Enrollment (Estimated): 845
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elvia Malo; Phone Number: +390456014854; Email: ricerca.clinica@sacrocuore.it

Study Locations

• Italy
  • Verona
    • Negrar, Verona, Italy
      • IRCCS Sacro Cuore Don Calabria di Negrar
      • Sub-Investigator: Dora Buonfrate
      • Contact: Marcello Ceccaroni, Doctor; Email: marcello.ceccaroni@sacrocuore.it
      • Contact: Phone Number: 0456013111
      • Principal Investigator: Marcello Ceccaroni

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria for study group:

• Age ≥ 18 years;
• endometriosis with clinical indication for either hysteroscopy or hysterectomy;
• signed informed consent to study participation and to personal data's treatment.

Inclusion Criteria for control group:

• 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 for both groups:

• lack of signed informed consent;
• Menopause
• antibiotic therapy in the 30 days before samples collection (including vaginal and cervical swab).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Study arm; Patients in reproductive age, who will undergo elective surgery for endometriosis.	Diagnostic test: 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.
Other: Control arm; Women in reproductive age, without endometriosis, as control group for secondary objective 1 and 2.	Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Fusobacterium sp presence (Y/N) in endometrial biopsy in women with endometriosis	At surgical intervention

Secondary Outcome Measures

Outcome Measure	Time Frame
Fusobacterium presence (Y/N) in endometrial biopsy in women without endometriosis	At surgical intervention
Fusobacterium presence (Y/N) in vaginal and cervical swab in all women enrolled	At preoperative visit
Fusobacterium presence (Y/N) in endometrial biopsy in women with and without PID complicating endometriosis .	At surgical intervention
Fusobacterium presence (Y/N) in biopsies of endometrial tissue involving different sites (superficial lesions, deep endometriosis, ovarian endometrioma), if present	At surgical intervention
Fusobacterium presence (Y/N) in endometrial biopsy in women with and without infertility associated to endometriosis	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	At surgical intervention

Collaborators and Investigators

• Sponsor: IRCCS Sacro Cuore Don Calabria di Negrar

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: April 11, 2024
• First Submitted That Met QC Criteria: April 11, 2024
• First Posted (Actual): April 16, 2024

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Fusobacteriaceae Infections; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Endometriosis; Fusobacterium Infections
• Other Study ID Numbers: 2024-04

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No