Back to resultsEndoSearch : Endometriosis Biomarkers
Primary Purpose
Endometriosis (Diagnosis), Blood Biomarkers, Endometrium Biomarkers
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Assessment of endometrium and blood biomarkers for endometriosis diagnosis
Sponsored by
About this trial
This is an interventional diagnostic trial for Endometriosis (Diagnosis)
Eligibility 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.
Sites / Locations
- EndodiagRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Patients in EndoSearch
Arm Description
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.
Outcomes
Primary Outcome Measures
Sensibility for endometriosis diagnosis (probability of detection)
Measurement of the proportion of positives patient that are correctly identified as such for the endometriosis diagnosis.
Specificity for endometriosis diagnosis
Measurement of the proportion of negatives patient that are correctly identified as such for the endometriosis diagnosis
Secondary Outcome Measures
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.
Specificity for endometriosis recurrence prognostic
Measurement of the proportion of negatives patient that are correctly identified as such for the endometriosis recurrence prognostic.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03376451
Brief Title
EndoSearch : Endometriosis Biomarkers
Official Title
Validation of Specific Biomarkers for the Diagnosis of Endometriosis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
September 1, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr Afchine Fazel
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis (Diagnosis), Blood Biomarkers, Endometrium Biomarkers
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
975 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients in EndoSearch
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Assessment of endometrium and blood biomarkers for endometriosis diagnosis
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sensibility for endometriosis diagnosis (probability of detection)
Description
Measurement of the proportion of positives patient that are correctly identified as such for the endometriosis diagnosis.
Time Frame
Comparison between diagnosis lab result and anatomopathologist diagnosis at the end of inclusion phase (9 months after 1st patient inclusion)
Title
Specificity for endometriosis diagnosis
Description
Measurement of the proportion of negatives patient that are correctly identified as such for the endometriosis diagnosis
Time Frame
Comparison between diagnosis lab result and anatomopathologist diagnosis at the end of inclusion phase (9 months after 1st patient inclusion)
Secondary Outcome Measure Information:
Title
Sensibility for endometriosis recurrence prognostic (probability of detection)
Description
Measurement of the proportion of positives patient that are correctly identified as such for the 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)
Title
Specificity for endometriosis recurrence prognostic
Description
Measurement of the proportion of negatives patient that are correctly identified as such for the 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)
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Endometriosis is a gynecological disease so we are only recruiting female subjects.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Juliette Delhaye, engineer
Phone
+33(0)7 62 62 92 94
Email
juliette.delhaye@endodiag.com
First Name & Middle Initial & Last Name or Official Title & Degree
Helene Beny, engineer
Phone
+33(0)9 62 50 72 93
Email
helene.beny@endodiag.com
Facility Information:
Facility Name
Endodiag
City
Paris
ZIP/Postal Code
75014
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juliette Delhaye, engineer
Phone
+33(0)7 60 62 92 94
Email
juliette.delhaye@endodiag.com
First Name & Middle Initial & Last Name & Degree
Helene Beny, engineer
Phone
+33(0)9 62 50 72 93
Email
helene.beny@endodiag.com
First Name & Middle Initial & Last Name & Degree
Afchine FAZEL, MD PhD
12. IPD Sharing Statement
Plan to Share IPD
No
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EndoSearch : Endometriosis Biomarkers
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