Blood and Tissue Markers for Improving Diagnosis and Prognosis of Endometriosis. (ENDOBIO)

Официальное название

Blood and Tissue Markers for Improving Diagnosis and Prognosis of Endometriosis. a Prospective Multicenter Nationwide Study. (ENDOBIO)

Обзор

Endometriosis is a chronic, benign, estrogen-dependent disease characterized by endometrial tissue that is implanted outside the uterus into the ovaries, intestines, or peritoneum but also outside the pelvis. It is a common disease that affects 7-10% of women around the world. The most common symptoms are pain and infertility. The diagnosis is histological after removal of lesions with laparoscopy (sensitivity 94%, specificity 79%), and treatment is symptomatic. At present, there is not a laboratory test that allows early and adequate diagnosis of endometriosis and therefore it can take up to 10 years for a patient to be diagnosed and patients often suffer from the disease. The purpose of our study is to investigate biomarkers associated with endometriosis and prove their use in the diagnosis and staging of endometriosis. The biomarkers will be studied even in relationship to clinical manifestations of the disease, as markers of relapse and as fertility markers. Meanwhile, quality of life of patients with advanced stages of endometriosis postoperatively will be studied.

Вмешательства

• Диагностический тест Blood biomarkers
  Blood biomarkers in plasma and serum.

Первичные конечные точки

• Measurement of blood biomarkers panel for the diagnosis of endometriosis with sensitivity 94% [Срок оценки: Preoperative]
• Change in blood biomarkers levels 3-6 months postoperative in patients with severe endometriosis. [Срок оценки: 3-6 months postoperative in the severe/DIE group]
• Measurement of blood biomarkers panel for the diagnosis of endometriosis with specificity 79% [Срок оценки: Preoperative]

Вторичные конечные точки (2)

• Quality of life of patients undergoing surgery for DIE [Срок оценки: Preoperative and 3-6 months postoperative in the severe/DIE group]
• Achieved pregnancy postoperative [Срок оценки: One year postoperative]

Критерии участия

IInclusion Criteria:

• women of reproductive age (18-45) who are operated because of suspected endometriosis (dysmenorrhea, dyspareunia, infertility, etc.) (patient group)
• women of reproductive age (18-45) who are operated for other benign gynecological causes with laparoscopy (ovarian cysts, sterilization, fibroids, etc.) and are found without macroscopic endometriosis perioperatively and confirmed with blind biopsies (control group
• talk swedish or english in order to complete questionnaires and give informed consent for their participation in the study.

Критерии исключения

• BMI> 40
• postmenopausal women
• premature ovarian failure
• pelvic inflammatory disease (PID)
• current or previous malignancy
• pregnancy and 6 months postpartum
• corticosteroids in the last 3 months
• pituitary, kidney, liver, adrenal disease
• endometrial hyperplasia or endometrial polyp
• cardiovascular or systemic inflammatory diseases.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Швеция · 3 центра

• Karolinska Universitetssjukhus Huddinge — Stockholm
• Södersjukhuset Kvinnokliniken — Stockholm
• Akademiska Uppsala — Uppsala

Идентификаторы

NCT: NCT05339451 · K 2022-2797

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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