Clinical trial NCT03376451: EndoSearch : Endometriosis Biomarkers
Official title: Validation of Specific Biomarkers for the Diagnosis of Endometriosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Endometriosis (Diagnosis)
Blood Biomarkers
Endometrium Biomarkers
Lead sponsor: Endodiag
Sponsor class: INDUSTRY
First posted: 2017-12-18
Enrollment: 975
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: EndoSearch recruits two groups of patients : affected by endometriosis and unaffected (controls) but both of them need a surgery for different indication (endometriosis for patients and other for controls (i.e dermoid cyst).
Primary purpose: DIAGNOSTIC

Brief summary: EndoSearch aims to analytically validate a cluster of specific biomarkers for endometriosis diagnosis and disease recurrence. This signature will be tested on endometrium and blood from 975 patients, divided in two groups : 550 patients affected by endometriosis and 225 patients unaffected (controls).

EndoSearch is not about drug or medical device assessment but a research study for biomarker analytical validation purpose.

Detailed description: Endometriosis is a very common gynecological disease affecting 10% of women of reproductive age. Main symptoms are chronic and severe pain in pelvis area and infertility in up to 40% of affected women. Currently, the only method to obtain a reliable diagnosis is the analysis of endometriotic lesions removed during surgery under general anaesthesia. There is a real need to diagnosis endometriosis non-invasively and quickly in order to improve patient management.

EndoSearch aims to analytically validate a cluster of endometrial and blood biomarkers identified in previous studies and specific for the endometriosis diagnosis and disease prognosis recurrence. During 2 years (follow up period) and 9 months (inclusion period), 15 clinical centers worldwide will recruit patients and collect biological samples and personal and clinical data from these patients. The biological samples will be processed at Endodiag labs, Paris, France though lab biotechnology techniques. Results will allow the assessment of sensibility and specificity (NPV and PPV) of the biomarker signature for endometriosis diagnosis and disease recurrence.

Eligibility criteria: Inclusion Criteria for endometriosis patients :

* Woman, from 18 to 45
* Patients with endometriosis suspicion, associated adenomyosis is accepted
* Freely signature of the consent form
* Patient needs laparoscopy for endometriosis purpose (first intervention or recurrence) regardless of the endometriosis type (superficial, ovarian or deep)
* Possibility of follow up during 2 years.

Inclusion Criteria for Healthy voluntary patients:

* Woman 18 to 45
* Freely signature of the consent form
* Patient needs laparoscopy for another indication than endometriosis, adenomyosis, uterine fibroma \& other fibroid pathologies (ex of surgeries: tubular sterilization, ovarian non-fibroid cyst, urinary incontinence requiring ureteral intervention).

Exclusion Criteria for endometriosis patients :

* Refusal or linguistic or psychic incapacity to sign informed consent
* No internet access or refusal to use new technologies
* Minor woman (under 18 years old)
* Pregnancy or breastfeeding
* Menopause
* Evidence of adenomyosis without endometriosis
* All metabolic pathology, endocrine, chronical infectious or malignant.
* Endometriosis negative result at visual and histological examination by anatomopathologist of the clinical centre.

Exclusion Criteria for Healthy voluntary patients

* Refusal or linguistic or psychic incapacity to sign informed consent
* No internet access or refusal to use new technologies
* Minor woman (under 18 years old)
* Pregnancy or breastfeeding
* Menopause
* Adenomyosis
* All metabolic pathology, endocrine, chronical infectious or malignant.
* Endometriosis positive result at visual and histological examination by anatomopathologist of the clinical centre.

Primary outcomes:
measure: Sensibility for endometriosis diagnosis (probability of detection)
timeFrame: Comparison between diagnosis lab result and anatomopathologist diagnosis at the end of inclusion phase (9 months after 1st patient inclusion)
measure: Specificity for endometriosis diagnosis
timeFrame: Comparison between diagnosis lab result and anatomopathologist diagnosis at the end of inclusion phase (9 months after 1st patient inclusion)
Secondary outcomes:
measure: Sensibility for endometriosis recurrence prognostic (probability of detection)
timeFrame: Comparison between recurrence lab result and eCRF data on recurrence at the end of study (2 years and 9 months)
measure: Specificity for endometriosis recurrence prognostic
timeFrame: Comparison between recurrence lab result and eCRF data on recurrence at the end of study (2 years and 9 months)
Other outcomes:
Locations:
city: Paris
country: France
facility: Endodiag
Study officials:
References: