EndoSearch : Endometriosis Biomarkers

Validation of Specific Biomarkers for the Diagnosis of Endometriosis

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.

Study Overview

• Status: Recruiting
• Conditions: Endometriosis (Diagnosis); Blood Biomarkers; Endometrium Biomarkers
• Intervention / Treatment: Other: Assessment of endometrium and blood biomarkers for endometriosis diagnosis

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 Type: Interventional
• Enrollment (Anticipated): 975
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Juliette Delhaye, engineer; Phone Number: +33(0)7 62 62 92 94; Email: juliette.delhaye@endodiag.com
• Study Contact Backup: Name: Helene Beny, engineer; Phone Number: +33(0)9 62 50 72 93; Email: helene.beny@endodiag.com

Study Locations

• France
  • Paris, France, 75014
    • Recruiting
    • Endodiag
    • Contact: Helene Beny, engineer; Phone Number: +33(0)9 62 50 72 93; Email: helene.beny@endodiag.com
    • Contact: Juliette Delhaye, engineer; Phone Number: +33(0)7 60 62 92 94; Email: juliette.delhaye@endodiag.com
    • Principal Investigator: Afchine FAZEL, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 41 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Dr Afchine Fazel

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Anticipated): September 1, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: November 29, 2017
• First Submitted That Met QC Criteria: December 13, 2017
• First Posted (Actual): December 18, 2017

Study Record Updates

• Last Update Posted (Actual): May 12, 2022
• Last Update Submitted That Met QC Criteria: May 11, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Endometriosis
• Other Study ID Numbers: 2017-A01445-48

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No