Diagnostic and Prognostic Markers of Endometriosis in Menstrual Blood

ConditionEndometriosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-45
SponsorInstitut National de la Santé Et de la Recherche Médicale, France

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 volunteers

Qualifiers

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

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

250 Participants
are grouped into 2 trial groups
Group A: With endometriosis
Group B: Without endometriosis

Trial outcomes

Primary outcomes

1

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%.

Time frame
3 years and 8 months

Secondary outcomes

1

Diagnostic score

Score based on candidate biomarkers that will be selected for their quantitative differences between patients with or without endometriosis.

Time frame
3 years and 8 months
2

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.

Time frame
3 years and 8 months
3

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%.

Time frame
3 years and 8 months

Other outcomes

Sponsors and contacts

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