Study on the Ultrasound and Biological Characteristics of Atypical Endometriosis.

NCT07816133 | Recruiting DMC

• 1 other identifier: 982CET
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This study hypothesizes that the histological, immunophenotypic, and molecular characterization of atypical endometriotic lesions may be related to specific clinical and ultrasound features.Identifying potentially atypical lesions would allow for more accurate stratification of patients, distinguishing definitely benign from potentially atypical endometriosis. The targeted study of endometriosis, both typical and atypical, also with reference to the inflammatory microenvironment, as well as immunophenotypic and molecular characteristics, could allow the formulation of pathogenic hypotheses on the development and progression of atypia towards malignant neoplasms.

Conditions

Endometriosis

Keywords

endometrioma; immunohistochemical and molecular analysis; anatomopathological analysis

Outcome Measures

Primary Outcomes (1)

• Identification of specific histopathological, immunohistochemical and molecular biology features for definable "atypical", "preneoplastic" or "cancerized-neoplastic" lesions and the surrounding microenvironment

  through study completion, an average of 1 year

Secondary Outcomes (1)

• Identification of specific ultrasound features of lesions described in histological examination as "atypical", "preneoplastic", or "cancerized-neoplastic"

  through study completion, an average of 1 year

Study Arms (2)

prospective observational group

Other: prospective case-control group

retrospective observational group

Other: Retrospective case-control analysis

Interventions

Retrospective case-control analysis OTHER

Single-center observational retrospective study with case collection starting June 2024

retrospective observational group

prospective case-control group OTHER

Single-center prospective observational study with recruitment of new cases for 30 months from the start of the project.

prospective observational group

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients undergoing laparoscopic surgery for benign or malignant (endometrial or ovarian) pathology

You may qualify if:

• Age \> 18 years
• Candidate patients for endometriosis surgery with deep endometriosis (intestine, LUS) and/or endometrioma localizations.
• Patients who are candidates for surgery for established or suspected endometrial and/or ovarian neoplasm
• Patients who have performed a level II gynecological ultrasound with an experienced operator in the preoperative process.
• Patients where there is the technical possibility of performing a transvaginal and/or transrectal ultrasound and the patient's willingness to undergo such an investigation.
• Signing of informed consent.

You may not qualify if:

• Technical impossibility of performing a transvaginal ultrasound (patient virgo, patient refusal).
• Previous neoplasms
• Patient who does not provide their informed consent.

Sponsors & Collaborators

• Casa di Cura Dott. Pederzoli: lead

Study Sites (1)

Ospedale P. Pederzoli Casa di Cura Privata S.p.A.

Peschiera del Garda, Verona, 37019, Italy

RECRUITING

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2026
• First Posted: September 11, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: September 11, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)