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.
Tutkimuksen yleiskatsaus
Tila
Ehdot
Interventio / Hoito
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Yhteystiedot ja paikat
Opiskelupaikat
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Verona
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Peschiera del Garda, Verona, Italia, 37019
- Rekrytointi
- Ospedale P. Pederzoli Casa di Cura Privata S.p.A.
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Ottaa yhteyttä:
- Daniele Mautone, MD
- Puhelinnumero: +39 0456444193
- Sähköposti: urc@ospedalepederzoli.it
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Näytteenottomenetelmä
Tutkimusväestö
Kuvaus
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.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
Kohortit ja interventiot
Ryhmä/Kohortti |
Interventio / Hoito |
|---|---|
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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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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Aikaikkuna |
|---|---|
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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
Aikaikkuna: through study completion, an average of 1 year
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through study completion, an average of 1 year
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Aikaikkuna |
|---|---|
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Identification of specific ultrasound features of lesions described in histological examination as "atypical", "preneoplastic", or "cancerized-neoplastic"
Aikaikkuna: through study completion, an average of 1 year
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through study completion, an average of 1 year
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Yhteistyökumppanit ja tutkijat
Sponsori
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Arvioitu)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
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