Diagnostic and Prognostic Markers of Endometriosis in Menstrual Blood

Endometriosis Clinical Trial

— MultiMENDo  

Official title:

FINDING DIAGNOSTIC AND PROGNOSTIC MARKERS OF ENDOMETRIOSIS IN MENSTRUAL BLOOD FROM WOMEN OF REPRODUCTIVE AGE

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06245512
• Other study ID #: C22-75
• Secondary ID: 2023-A01857-38
• Status: Not yet recruiting
• Start date: March 2024
• Est. completion date: October 2027

Study information

• Verified date: January 2024
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: Ludivine Doridot
• Phone: 33(0)1 40 51 64 33
• Email: ludivine.doridot[@]inserm.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 250
• Est. completion date: October 2027
• Est. primary completion date: October 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

For all participants:

Women 18-45 of age who

• 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)

For participants with endometriosis:

• diagnosis of endometriosis established by surgery or imaging (ultrasound and/or MRI)
• presence of one or more painful symptoms > 3 on a visual scale (dysmenorrhea and/or dyspareunia and/or chronic pelvic pain) and/or infertility
• for the surgery subgroup: planned surgery in the next 3 months

For participants without endometriosis:

• painful symptoms < or equal to 3 on a visual scale (for dysmenorrhea and dyspareunia and chronic pelvic pain),
• absence of intense period pain in adolescence (leading to taking pills to control this pain and/or peri-menstrual school absenteeism) Exclusion Criteria:

For all participants:

• 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)
• History of menstrual toxic shock syndrome

For patients with endometriosis:

• endometriosis surgery within the last 3 months.

Related Conditions & MeSH terms

• Endometriosis

Locations

Country	Name	City	State
France	Hopital Cochin	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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%.	3 years and 8 months
Secondary	Diagnostic score	Score based on candidate biomarkers that will be selected for their quantitative differences between patients with or without endometriosis.	3 years and 8 months
Secondary	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.	3 years and 8 months
Secondary	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%.	3 years and 8 months