EndoSearch : Endometriosis Biomarkers

NCT ID: NCT03376451

Last Updated: 2022-05-12

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

975 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2022-12-31

Brief Summary

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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

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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.

Conditions

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Endometriosis (Diagnosis) Blood Biomarkers Endometrium Biomarkers

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

DIAGNOSTIC

Blinding Strategy

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.

Group Type OTHER

Assessment of endometrium and blood biomarkers for endometriosis diagnosis

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.


* 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

* 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.


* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Dr Afchine Fazel

INDUSTRY

Sponsor Role lead

Responsible Party

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Dr Afchine Fazel

MD PhD

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Endodiag

Paris, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Juliette Delhaye, engineer

Role: CONTACT

+33(0)7 62 62 92 94

Helene Beny, engineer

Role: CONTACT

+33(0)9 62 50 72 93

Facility Contacts

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Juliette Delhaye, engineer

Role: primary

+33(0)7 60 62 92 94

Helene Beny, engineer

Role: backup

+33(0)9 62 50 72 93

Other Identifiers

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2017-A01445-48

Identifier Type: -

Identifier Source: org_study_id

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