Clinical and Molecular Study of Endometriosis and Adenomyosis
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Biological/Vaccine.
- Кому может быть актуально
- Состояния в реестре: Endometriosis, Adenomyosis. Базовые параметры: 18 лет — 42 лет · Женщины.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Франция
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Официальное название
ENDOCHAP Monocentric Cohort: Clinical and Molecular Study of Endometriosis and Adenomyosis
Обзор
The purpose of this study is to determine whether endometriosis and adenomyosis are progressive diseases, in terms of symptoms (pain, abnormal uterine bleeding and infertility), anatomical lesions size, and recurrences. We also aimed to address molecular questions on immune dialogues between ectopic lesions and the eutopic endometrium, auto-immunity in endometriosis and adenomyosis and the role of the microbiota in their respective pathophysiologies.
Подробное описание
Endometriosis and adenomyosis are benign gynecological conditions which affect more than 10% of women, that typically cause pain and / or infertility, thereby exerting a negative impact on the patients' quality of life.
Although the pathogenesis of endometriosis and adenomyosis are controversial, both diseases are defined by the presence of endometrial tissue outside the uterine cavity. Endometriosis is a heterogeneous disease, with three phenotypes: superficial peritoneal endometriosis (SUP), ovarian endometrioma (OMA), and deep infiltrating endometriosis (DIE) The most widely accepted pathophysiological hypothesis for endometriosis is that of the implantation of ectopic endometrial cells following peritoneal reflux. Endometriosis can be associated with adenomyosis, also heterogeneous, characterized by the infiltration of endometrial tissue into the myometrium, presenting different forms: diffuse, focal or cystic.
Due to diseases heterogeneity, the diagnosis of endometriosis and adenomyosis is difficult and affected patients are subject to a long delay for appropriate management.
We hypothesize that the disease may be progressive in terms of symptoms (pain, abnormal uterine bleeding and infertility), anatomical lesions and recurrences. Furthermore, highlighting specific clinical and molecular markers would shorten the diagnostic time.
Вмешательства
- Биопрепарат Biological/Vaccine
Первичные конечные точки
- Pain scores (analog visual scale), quantification of uterine bleeding (number of towels or tampon/day/month) and live birth rates [Срок оценки: 10 years]
- Changes in lesions or recurrences to imaging performed during the gynaecological follow-up of the patient [Срок оценки: 10 years]
Вторичные конечные точки (12)
- Pain scores (analog visual scale), quantification of uterine bleeding (number of towels or tampon/day/month) and live birth rates [Срок оценки: 1 year]
- Pain scores (analog visual scale), quantification of uterine bleeding (number of towels or tampon/day/month) and live birth rates [Срок оценки: 3 years]
- Pain scores (analog visual scale), quantification of uterine bleeding (number of towels or tampon/day/month) and live birth rates [Срок оценки: 5 years]
- Pain scores (analog visual scale), quantification of uterine bleeding (number of towels or tampon/day/month) and live birth rates [Срок оценки: 7 years]
- Delays between the onset of symptoms and post-operative or radiological histological diagnosis with specialized imaging (transvaginal ultrasound, endorectal ultrasound, magnetic resonance imagingI [Срок оценки: 10 years]
- meeting specific criteria for endometriosis and adenomyosis lesions [Срок оценки: 10 years]
- Association between clinical parameters of interrogation and clinical examination and the presence of endometriosis. [Срок оценки: 10 years]
- Association between clinical parameters of interrogation and clinical examination and the presence of adenomyosis. [Срок оценки: 10 years]
- Association between clinical data and the occurrence of the disease [Срок оценки: 10 years]
- Creating a score on clinical diagnosis [Срок оценки: 10 years]
- - Evaluation of individualized management: comparison between different management strategies on pain scores (analog visual scale), pregnancy-conception desire delay, live birth rate [Срок оценки: 10 years]
- Serum dosage of circulating antibodies before and after surgical treatment of lesions [Срок оценки: 10 years]
Критерии участия
Критерии включения
- Women of age between - 18 and 42 years old.
- In-service care for one of the pelvic pain and/or infertility, or for a pelvic mass.
- Having a radiological diagnosis made by a referral practitioner and/or operated in the department
Критерии исключения
- HIV-positive women, HBV and HCV
- During pregnancy
- Having a cancer diagnosis
- Refusing to sign a consent.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Франция · 1 центр
- Port Royal, hospital cochin — Paris
Идентификаторы
NCT: NCT04481321 · NI18108