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.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Регистрация (Оцененный)
Контакты и местонахождение
Места учебы
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Verona
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Peschiera del Garda, Verona, Италия, 37019
- Рекрутинг
- Ospedale P. Pederzoli Casa di Cura Privata S.p.A.
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Контакт:
- Daniele Mautone, MD
- Номер телефона: +39 0456444193
- Электронная почта: urc@ospedalepederzoli.it
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Метод выборки
Исследуемая популяция
Описание
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.
Учебный план
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
|---|---|
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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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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Временное ограничение |
|---|---|
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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
Временное ограничение: through study completion, an average of 1 year
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through study completion, an average of 1 year
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Вторичные показатели результатов
Мера результата |
Временное ограничение |
|---|---|
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Identification of specific ultrasound features of lesions described in histological examination as "atypical", "preneoplastic", or "cancerized-neoplastic"
Временное ограничение: through study completion, an average of 1 year
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through study completion, an average of 1 year
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Соавторы и исследователи
Спонсор
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 982CET
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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