EndoSearch : Endometriosis Biomarkers
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|ClinicalTrials.gov Identifier: NCT03376451|
Recruitment Status : Recruiting
First Posted : December 18, 2017
Last Update Posted : April 28, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Endometriosis (Diagnosis) Blood Biomarkers Endometrium Biomarkers||Other: Assessment of endometrium and blood biomarkers for endometriosis diagnosis||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||975 participants|
|Intervention Model:||Single Group Assignment|
|Intervention 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)|
|Official Title:||Validation of Specific Biomarkers for the Diagnosis of Endometriosis|
|Actual Study Start Date :||January 1, 2018|
|Estimated Primary Completion Date :||January 1, 2021|
|Estimated Study Completion Date :||April 1, 2021|
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.
- Sensibility for endometriosis diagnosis (probability of detection) [ Time Frame: Comparison between diagnosis lab result and anatomopathologist diagnosis at the end of inclusion phase (9 months after 1st patient inclusion) ]Measurement of the proportion of positives patient that are correctly identified as such for the endometriosis diagnosis.
- Specificity for endometriosis diagnosis [ Time Frame: Comparison between diagnosis lab result and anatomopathologist diagnosis at the end of inclusion phase (9 months after 1st patient inclusion) ]Measurement of the proportion of negatives patient that are correctly identified as such for the endometriosis diagnosis
- Sensibility for endometriosis recurrence prognostic (probability of detection) [ Time Frame: Comparison between recurrence lab result and eCRF data on recurrence at the end of study (2 years and 9 months) ]Measurement of the proportion of positives patient that are correctly identified as such for the endometriosis recurrence prognostic.
- Specificity for 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) ]Measurement of the proportion of negatives patient that are correctly identified as such for the endometriosis recurrence prognostic.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03376451
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