pelvic pain and infertility caused by endometrial tissue outside of the uterus uterine disorder
Conditions
Interventions
The intervention is a laparoscopy planned for endometriosis diagnosis or
treatment (endo group) or other indication (control group). The surgery is not
performed specially for the study needs.
Sponsors
1988
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Voluntary patients with endometriosis * Women aged 18 to 45 years * Patients with suspicion of endometriosis; associated adenomyosis is accepted * Informed, voluntary signature of the consent form * Patient requiring laparoscopy for endometriosis purposes (first procedure or recurrence) regardless of the endometriosis type (superficial, ovarian or deep) * Possibility of follow-up for 2 years., Healthy voluntary patients * Women aged 18 to 45 years * Informed, voluntary signature of the consent form * Patient requiring laparoscopy for an indication other than endometriosis, adenomyosis, uterine fibroma & other fibroid pathologies (example of possible surgeries: tubal sterilization, non-fibroid ovarian cyst, urinary incontinence requiring ureteral intervention).
Exclusion criteria
Exclusion criteria: Voluntary patients with endometriosis * Refusal or linguistic or psychic incapacity to sign informed consent * No internet access or refusal to use new technologies * Minors (under 18 years old) * Pregnancy or breastfeeding * Menopause * Evidence of adenomyosis alone, without endometriosis * Any metabolic, endocrine, chronic infectious or malignant pathology. * Negative result for endometriosis on visual and histological examination by pathologist at the clinical centre, Healthy voluntary patients * Refusal or linguistic or psychic incapacity to sign informed consent * No internet access or refusal to use new technologies * Minors (under 18 years old) * Pregnancy or breastfeeding * Menopause * Any metabolic, endocrine, chronic infectious or malignant pathology. * Positive result for endometriosis on visual and histological examination by pathologist at the clinical centre.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoints The analytical validation of biomarkers identified in the diagnosis of endometriosis will be based on the following results: - Immunohistochemistry localization marking; - Immunohistochemistry marking rate; - Differential expression profile of microRNA. The possibility, with biomarkers and an associated algorithm, to differentiate between endometriosis patients versus healthy control patients. The primary endpoints will be determined from analysis results and are composed of sensitivity, specificity, NPV and PPV. These criteria will allow a conclusion on biomarker signature performance in diagnosing endometriosis. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints The analytical validation of biomarkers for the prognosis of endometriosis recurrence will be based on: - Immunohistochemistry localization marking; - Immunohistochemistry marking rate; - Differential expression profile of microRNA. The possibility, with biomarkers and an associated algorithm, to identify endometriosis patients in recurrence after 2 years of follow-up The secondary endpoints will be determined from analysis results and are composed of sensitivity, specificity, NPV and PPV. These criteria will allow a conclusion on biomarker signature performance in predicting endometriosis recurrence for each patient. | — |
Countries
Netherlands
Outcome results
None listed