Diagnostic and Prognostic Markers of Endometriosis in Menstrual Blood

NCT06245512 | Recruiting

• 2 other identifiers: C22-752023-A01857-38
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Endometriosis

Keywords

biomarker; diagnosis; prognosis

Outcome Measures

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%.

  3 years and 8 months

Secondary Outcomes (3)

• Diagnostic score

  3 years and 8 months

• Prognostic candidate score

  3 years and 8 months

• Diagnostic score for a specific subtype of endometriosis

  3 years and 8 months

Study Arms (2)

With endometriosis

Women affected by endometriosis

Without endometriosis

Women without any clinical sign of endometriosis

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women 18-45 of age with periods

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead

Study Sites (1)

Hopital Cochin

Paris, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Menstrual blood

MeSH Terms

Conditions

Endometriosis; Disease

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Louis Marcellin

  Institut National de la Santé Et de la Recherche Médicale, France

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ludivine Doridot

CONTACT

33(0)1 40 51 64 33; ludivine.doridot@inserm.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2024
• First Posted: February 7, 2024
• Study Start: July 31, 2024
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): March 30, 2027
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

FR (1)