Study on the Ultrasound and Biological Characteristics of Atypical Endometriosis.
ConditionEndometriosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorCasa di Cura Dott. Pederzoli
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Technical impossibility of performing a transvaginal ultrasound (patient virgo, patient refusal).
Previous neoplasms
Patient who does not provide their informed consent.
Trial population
patients undergoing laparoscopic surgery for benign or malignant (endometrial or ovarian) pathology
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
Retrospective case-control analysis
Other interventionSingle-center observational retrospective study with case collection starting June 2024
prospective case-control group
Other interventionSingle-center prospective observational study with recruitment of new cases for 30 months from the start of the project.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: prospective observational group1 intervention
Group B: retrospective observational group1 intervention
Trial outcomes
Primary outcomes
1
Identification of specific histopathological, immunohistochemical and molecular biology features for definable "atypical", "preneoplastic" or "cancerized-neoplastic" lesions and the surrounding microenvironment
Time frame
through study completion, an average of 1 yearSecondary outcomes
1
Identification of specific ultrasound features of lesions described in histological examination as "atypical", "preneoplastic", or "cancerized-neoplastic"
Time frame
through study completion, an average of 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov