About this trial
The goal of this observational study is to identify diagnostic and prognostic biomarkers for endometriosis using menstrual blood, an easily accessible yet overlooked biological fluid in women of reproductive age, affected or not by endometriosis
The main questions it aims to answer are:
* are there relevant differences in the menstrual blood of women affected by endometriosis compared to women without endometriosis? * do some of these differences disappear or lessen when the disease is treated by surgery? Participants will answer questions relevant to endometriosis and provide menstrual blood 1 to 3 times (self-collected with a menstrual cup). A subgroup of participants affected by endometriosis that will undergo surgery for their regular care will provide menstrual blood before and after their surgery.
Researchers will compare the menstrual blood of women with and without endometriosis, and before and after surgery to see if they can identify significant differences.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Have their period
Have given their written consent
Have already used a menstrual cup as a method of hygienic protection
Residing or working in Ile de France (Paris Metropolitan area, France)
Disqualifiers
Autoimmune diseases
Chronic diseases other than endometriosis (diabetes, hypertension)
A person who is the subject of a judicial safeguard measure (by declaration)
Infectious diseases (HIV, HBV, if known)
Trial population
Women 18-45 of age with periods
Trial design
Case-control
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Diagnostic and prognostic score
Score based on candidate biomarkers that will be selected for their quantitative differences between patients with or without endometriosis and for their prognostic potential in the context of response to surgical treatment (significant quantitative difference between before and after surgery). Biomarkers that are both significantly quantitatively different between women with and without endometriosis and before versus after surgery will constitute the final set and this set will be measured by targeted approach in all the participants. This score, associated or not with clinical characteristics (such as for example the intensity of pain, the association of different types of pain), will make it possible to differentiate women with and without endometriosis with a specificity greater than or equal to 79% and a sensitivity greater than or equal to 94%.
Secondary outcomes
Diagnostic score
Score based on candidate biomarkers that will be selected for their quantitative differences between patients with or without endometriosis.
Prognostic candidate score
Score based on candidate biomarkers that will be selected for their significant quantitative differences between before and after surgery. This score will have to be validated in a bigger cohort in a subsequent clinical study to assess its specificity and sensitivity to differentiate women for who the surgery is effective from women for who the surgery is not or only partially effective, or women with a recurrence of the disease.
Diagnostic score for a specific subtype of endometriosis
Score based on candidate biomarkers that will be selected for their quantitative differences between the patients with different subtypes of endometriosis. This score, associated or not with clinical characteristics (such as for example the intensity of pain, the association of different types of pain), will make it possible to differentiate women with a specific subtype of endometriosis with a specificity greater than or equal to 79% and a sensitivity greater than or equal to 94%.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.