EndoSearch : Endometriosis Biomarkers

Blood Biomarkers Clinical Trial

Official title:

Validation of Specific Biomarkers for the Diagnosis of Endometriosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03376451
• Other study ID #: 2017-A01445-48
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: December 31, 2022

Study information

• Verified date: May 2022
• Source: Endodiag
• Contact: Juliette Delhaye, engineer
• Phone: +33(0)7 62 62 92 94
• Email: juliette.delhaye[@]endodiag.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 975
• Est. completion date: December 31, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Blood Biomarkers
• Endometriosis
• Endometriosis (Diagnosis)
• Endometrium Biomarkers

Intervention

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.

Locations

Country	Name	City	State
France	Endodiag	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Dr Afchine Fazel

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)
Secondary	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)