Validation of specific biomarkers for the diagnosis of endometriosis
- Conditions
- pelvic pain and infertility caused by endometrial tissue outside of the uterusuterine disorder10046828
- Registration Number
- NL-OMON49755
- Lead Sponsor
- 1988
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 65
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).
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary endpoints<br /><br>The analytical validation of biomarkers identified in the diagnosis of<br /><br>endometriosis will be based on the following results:<br /><br>- Immunohistochemistry localization marking;<br /><br>- Immunohistochemistry marking rate;<br /><br>- Differential expression profile of microRNA.<br /><br>The possibility, with biomarkers and an associated algorithm, to differentiate<br /><br>between endometriosis patients versus healthy control patients.<br /><br><br /><br>The primary endpoints will be determined from analysis results and are composed<br /><br>of sensitivity, specificity, NPV and PPV. These criteria will allow a<br /><br>conclusion on biomarker signature performance in diagnosing endometriosis.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints<br /><br><br /><br>The analytical validation of biomarkers for the prognosis of endometriosis<br /><br>recurrence will be based on:<br /><br>- Immunohistochemistry localization marking;<br /><br>- Immunohistochemistry marking rate;<br /><br>- Differential expression profile of microRNA.<br /><br>The possibility, with biomarkers and an associated algorithm, to identify<br /><br>endometriosis patients in recurrence after 2 years of follow-up<br /><br><br /><br>The secondary endpoints will be determined from analysis results and are<br /><br>composed of sensitivity, specificity, NPV and PPV. These criteria will allow a<br /><br>conclusion on biomarker signature performance in predicting endometriosis<br /><br>recurrence for each patient.</p><br>