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EndoSearch : Endometriosis Biomarkers

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ClinicalTrials.gov Identifier: NCT03376451
Recruitment Status : Recruiting
First Posted : December 18, 2017
Last Update Posted : April 28, 2020
Sponsor:
Information provided by (Responsible Party):
Dr Afchine Fazel, Endodiag

Study Description
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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.


Condition or disease Intervention/treatment Phase
Endometriosis (Diagnosis) Blood Biomarkers Endometrium Biomarkers Other: Assessment of endometrium and blood biomarkers for endometriosis diagnosis Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 975 participants
Allocation: N/A
Intervention Model: Single Group Assignment
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).
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Validation of Specific Biomarkers for the Diagnosis of Endometriosis
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : April 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis

Arms and Interventions
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Arm Intervention/treatment
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.
 Other: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Sensibility for endometriosis diagnosis (probability of detection) [ Time Frame: Comparison between diagnosis lab result and anatomopathologist diagnosis at the end of inclusion phase (9 months after 1st patient inclusion) ]
    Measurement of the proportion of positives patient that are correctly identified as such for the endometriosis diagnosis.

  2. Specificity for endometriosis diagnosis [ Time Frame: Comparison between diagnosis lab result and anatomopathologist diagnosis at the end of inclusion phase (9 months after 1st patient inclusion) ]
    Measurement of the proportion of negatives patient that are correctly identified as such for the endometriosis diagnosis


Secondary Outcome Measures :
  1. Sensibility for endometriosis recurrence prognostic (probability of detection) [ Time Frame: Comparison between recurrence lab result and eCRF data on recurrence at the end of study (2 years and 9 months) ]
    Measurement of the proportion of positives patient that are correctly identified as such for the endometriosis recurrence prognostic.

  2. Specificity for endometriosis recurrence prognostic [ Time Frame: Comparison between recurrence lab result and eCRF data on recurrence at the end of study (2 years and 9 months) ]
    Measurement of the proportion of negatives patient that are correctly identified as such for the endometriosis recurrence prognostic.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Endometriosis is a gynecological disease so we are only recruiting female subjects.
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03376451


Contacts
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Contact: Jennifer Lourenco, engineer +33(0)9 62 50 72 93 jennifer.lourenco@endodiag.com
Contact: Helene Beny, engineer +33(0)9 62 50 72 93 helene.beny@endodiag.com

Locations
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France
Endodiag Recruiting
Paris, France, 75014
Contact: Jennifer Lourenco, engineer    +33(0)9 62 50 72 93    jennifer.lourenco@endodiag.com   
Contact: Helene Beny, engineer    +33(0)9 62 50 72 93    helene.beny@endodiag.com   
Principal Investigator: Afchine FAZEL, MD PhD         
Sponsors and Collaborators
Dr Afchine Fazel
More Information
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Responsible Party: Dr Afchine Fazel, MD PhD, Endodiag
ClinicalTrials.gov Identifier: NCT03376451    
Other Study ID Numbers: 2017-A01445-48
First Posted: December 18, 2017    Key Record Dates
Last Update Posted: April 28, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Endometriosis
Genital Diseases, Female