EndoSearch : Endometriosis Biomarkers

NCT03376451 | Unknown DMC

• 1 other identifier: 2017-A01445-48
• Study Type: interventional
• Target: 975
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometriosis (Diagnosis); Blood Biomarkers; Endometrium Biomarkers

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Sensibility for endometriosis recurrence prognostic (probability of detection)

  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

  Comparison between recurrence lab result and eCRF data on recurrence at the end of study (2 years and 9 months)

Study Arms (1)

Patients in EndoSearch

OTHER

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

Interventions

Assessment of endometrium and blood biomarkers for endometriosis diagnosis 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.

Patients in EndoSearch

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Endometriosis is a gynecological disease so we are only recruiting female subjects.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr Afchine Fazel: lead

Study Sites (1)

Endodiag

Paris, 75014, France

RECRUITING

MeSH Terms

Conditions

Endometriosis; Disease

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Juliette Delhaye, engineer

CONTACT

+33(0)7 62 62 92 94; juliette.delhaye@endodiag.com

Helene Beny, engineer

CONTACT

+33(0)9 62 50 72 93; helene.beny@endodiag.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD PhD

Model Details: 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).

Study Record Dates

• First Submitted: November 29, 2017
• First Posted: December 18, 2017
• Study Start: January 1, 2018
• Primary Completion: September 1, 2022
• Study Completion: December 31, 2022
• Last Updated: May 12, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)