NCT03376451

EndoSearch : Endometriosis Biomarkers

Validation of Specific Biomarkers for the Diagnosis of Endometriosis

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 975 (estimated)
• Sponsor: Dr Afchine Fazel · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Endometriosis (Diagnosis)
• Blood Biomarkers
• Endometrium Biomarkers

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-01-01
• Primary completion: 2022-09-01
• Completion: 2022-12-31
• First posted: 2017-12-18
• Last updated: 2022-05-12

Locations

1 site across 1 country: France