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

NCT06368596 | Not Yet Recruiting

• 1 other identifier: 2024-04
• Study Type: interventional
• Target: 845
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Endometriosis

Outcome Measures

Primary Outcomes (1)

• Fusobacterium sp presence (Y/N) in endometrial biopsy in women with endometriosis

  At surgical intervention

Secondary Outcomes (6)

• 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

Study Arms (2)

Study arm

OTHER

Patients in reproductive age, who will undergo elective surgery for endometriosis.

Diagnostic Test: Fusobacterium detection

Control arm

OTHER

Women in reproductive age, without endometriosis, as control group for secondary objective 1 and 2.

Diagnostic Test: Fusobacterium detection

Interventions

Fusobacterium detection DIAGNOSTIC_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.

Control arm; Study arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• IRCCS Sacro Cuore Don Calabria di Negrar: lead

Study Sites (1)

IRCCS Sacro Cuore Don Calabria di Negrar

Negrar, Verona, Italy

Location

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Elvia Malo

CONTACT

+390456014854; ricerca.clinica@sacrocuore.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2024
• First Posted: April 16, 2024
• Study Start: April 1, 2024
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: April 16, 2024

Record last verified: 2024-04

Locations

IT (1)