Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
975 participants
INTERVENTIONAL
2018-01-01
2022-12-31
Brief Summary
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EndoSearch is not about drug or medical device assessment but a research study for biomarker analytical validation purpose.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Patients in EndoSearch
EndoSearch will conduct on only one cohort divided in two groups : patients affected by endometriosis and patient unaffected (controls). All of these patients need a laparoscopic surgery for endometriosis indication (endometriosis group) or another indication which is not endometriosis (controls). However, nothing in the surgery or the patient medical care will be different between the two groups : patients will be treated exactly the same.
Assessment of endometrium and blood biomarkers for endometriosis diagnosis
Biological samples will be collected from patients, sent to Endodiag, Paris, in France and be processed through IHC and molecular biology techniques to assess the ability of the identified biomarkers signature to diagnose and prognose endometriosis.
Interventions
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Assessment of endometrium and blood biomarkers for endometriosis diagnosis
Biological samples will be collected from patients, sent to Endodiag, Paris, in France and be processed through IHC and molecular biology techniques to assess the ability of the identified biomarkers signature to diagnose and prognose endometriosis.
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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
* 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.
* 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.
18 Years
45 Years
FEMALE
Yes
Sponsors
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Dr Afchine Fazel
INDUSTRY
Responsible Party
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Dr Afchine Fazel
MD PhD
Locations
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Endodiag
Paris, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2017-A01445-48
Identifier Type: -
Identifier Source: org_study_id
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