Study on the Ultrasound and Biological Characteristics of Atypical Endometriosis. (ENDOAT)
Endometriosis "Atypical" and Cancerized: Anatomopathological and Clinical-instrumental Characterization on the Ultrasound and Biological Characteristics of Atypical Endometriosis.
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Observational, retrospective-prospective, cross-sectional, single-center study conducted on patients undergoing laparoscopic surgery for benign or malignant pathology (endometrial or ovarian). The study does not include changes to the standard care pathway and all procedures are in normal clinical practice. The indication for surgical treatment is formulated on the basis of the most up-to-date guidelines on the subject. The study includes two phases:
- Single-center observational retrospective study with case collection starting June 2024
- Single-center prospective observational study with recruitment of new cases for 30 months after the start of the project.
At the time of the pre-hospitalization visit, the patient will be clearly and understandably illustrated with the rationale and objective of the study, the planned procedures (which do not deviate from normal clinical practice) and the data that are intended to be collected for each patient. There are four groups under comparison: patients with endometriosis without atypia and patients with neoplasia not associated with endometriosis represent the "controls", while patients with atypical endometriosis and patients with cancerized endometriosis or neoplasia associated with endometriosis represent the "cases". Patients with ovarian / endometrial neoplasia not associated with endometriosis will serve as a control for both the ultrasound appearance of the lesions and for anatomopathological analysis (including immunohistochemical and molecular investigations).
Patients included in the study will undergo a level II gynecological ultrasound with transvaginal technique by experienced operators, the images will be reviewed by two experienced operators.
Patients will be operated on by operators experienced in endometriosis surgery. The anatomopathological diagnostic report will be structured sec. International Collaboration on Cancer Reporting (ICCR) (Annexes 1 and 2), which includes essential elements ("core"), and optional elements ("non-core") (https://www.iccr-cancer.org/).
Each case will be evaluated individually and then in doubles by two anatomopathologists experienced in gynecological pathology.
The immunohistochemical and molecular panel are routinely performed in patients with atypical endometriosis, cancerized endometriosis, or endometriosis-associated neoplasia and in neoplasms not associated with endometriosis, therefore the performance of these procedures does not deviate from such clinical practice. In patients with endometriosis "typical", a reduced panel will be performed, if deemed necessary by the pathologist, particularly if there are dubious morphological pictures.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Lieux d'étude
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Verona
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Peschiera del Garda, Verona, Italie, 37019
- Recrutement
- Ospedale P. Pederzoli Casa di Cura Privata S.p.A.
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Contact:
- Daniele Mautone, MD
- Numéro de téléphone: +39 0456444193
- E-mail: urc@ospedalepederzoli.it
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Technical impossibility of performing a transvaginal ultrasound (patient virgo, patient refusal).
- Previous neoplasms
- Patient who does not provide their informed consent.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
prospective observational group
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Single-center prospective observational study with recruitment of new cases for 30 months from the start of the project.
|
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retrospective observational group
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Single-center observational retrospective study with case collection starting June 2024
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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Identification of specific histopathological, immunohistochemical and molecular biology features for definable "atypical", "preneoplastic" or "cancerized-neoplastic" lesions and the surrounding microenvironment
Délai: through study completion, an average of 1 year
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through study completion, an average of 1 year
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
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Identification of specific ultrasound features of lesions described in histological examination as "atypical", "preneoplastic", or "cancerized-neoplastic"
Délai: through study completion, an average of 1 year
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through study completion, an average of 1 year
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 982CET
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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