Clinical and Molecular Study of Endometriosis and Adenomyosis (ENDOCHAP)

ENDOCHAP Monocentric Cohort: Clinical and Molecular Study of Endometriosis and Adenomyosis

The purpose of this study is to determine whether endometriosis and adenomyosis are progressive diseases, in terms of symptoms (pain, abnormal uterine bleeding and infertility), anatomical lesions size, and recurrences. We also aimed to address molecular questions on immune dialogues between ectopic lesions and the eutopic endometrium, auto-immunity in endometriosis and adenomyosis and the role of the microbiota in their respective pathophysiologies.

Study Overview

• Status: Recruiting
• Conditions: Endometriosis; Adenomyosis
• Intervention / Treatment: Biological: Biological/Vaccine

Detailed Description

Endometriosis and adenomyosis are benign gynecological conditions which affect more than 10% of women, that typically cause pain and / or infertility, thereby exerting a negative impact on the patients' quality of life.

Although the pathogenesis of endometriosis and adenomyosis are controversial, both diseases are defined by the presence of endometrial tissue outside the uterine cavity. Endometriosis is a heterogeneous disease, with three phenotypes: superficial peritoneal endometriosis (SUP), ovarian endometrioma (OMA), and deep infiltrating endometriosis (DIE) The most widely accepted pathophysiological hypothesis for endometriosis is that of the implantation of ectopic endometrial cells following peritoneal reflux. Endometriosis can be associated with adenomyosis, also heterogeneous, characterized by the infiltration of endometrial tissue into the myometrium, presenting different forms: diffuse, focal or cystic.

Due to diseases heterogeneity, the diagnosis of endometriosis and adenomyosis is difficult and affected patients are subject to a long delay for appropriate management.

We hypothesize that the disease may be progressive in terms of symptoms (pain, abnormal uterine bleeding and infertility), anatomical lesions and recurrences. Furthermore, highlighting specific clinical and molecular markers would shorten the diagnostic time.

• Study Type: Observational
• Enrollment (Anticipated): 5300

Contacts and Locations

• Study Contact: Name: Charles Chapron, MD; Phone Number: +33 1 58 41 19 33; Email: charles.chapron@aphp.fr
• Study Contact Backup: Name: Laurence Lecomte, PhD; Phone Number: +33 1 58 41 34 78; Email: laurence.lecomte@aphp.fr

Study Locations

• France
  • Paris, France, 75014
    • Recruiting
    • Port Royal, hospital cochin
    • Contact: Louis Marcellin, MD, PhD; Phone Number: +33 1 58415495; Email: louis.marcellin@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 40 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women of age between - 18 and 42 years old.

• In-service care for one of the pelvic pain and/or infertility, or for a pelvic mass.
• Having a radiological diagnosis made by a referral practitioner and/or operated in the department.

Description

Inclusion Criteria:

• Women of age between - 18 and 42 years old.
• In-service care for one of the pelvic pain and/or infertility, or for a pelvic mass.
• Having a radiological diagnosis made by a referral practitioner and/or operated in the department

Exclusion Criteria:

• HIV-positive women, HBV and HCV
• During pregnancy
• Having a cancer diagnosis
• Refusing to sign a consent.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patient with benign gynaecologic disease; Patients consulting for endometriosis, pelvic pain, abnormal uterine bleeding and/or infertility, or for a pelvic mass,	Biological: Biological/Vaccine; Other Names: Peripheral blood,; Vaginal and urinary swab; Endometriosis lesions,endometrial biopsies; Myometer biopsies; Peritoneal fluid; Follicular fluid biopsies

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain scores (analog visual scale), quantification of uterine bleeding (number of towels or tampon/day/month) and live birth rates	Composite outcome	10 years
Changes in lesions or recurrences to imaging performed during the gynaecological follow-up of the patient		10 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Pain scores (analog visual scale), quantification of uterine bleeding (number of towels or tampon/day/month) and live birth rates	1 year
Pain scores (analog visual scale), quantification of uterine bleeding (number of towels or tampon/day/month) and live birth rates	3 years
Pain scores (analog visual scale), quantification of uterine bleeding (number of towels or tampon/day/month) and live birth rates	5 years
Pain scores (analog visual scale), quantification of uterine bleeding (number of towels or tampon/day/month) and live birth rates	7 years
Delays between the onset of symptoms and post-operative or radiological histological diagnosis with specialized imaging (transvaginal ultrasound, endorectal ultrasound, magnetic resonance imagingI	10 years
meeting specific criteria for endometriosis and adenomyosis lesions	10 years
Association between clinical parameters of interrogation and clinical examination and the presence of endometriosis.	10 years
Association between clinical parameters of interrogation and clinical examination and the presence of adenomyosis.	10 years
Association between clinical data and the occurrence of the disease	10 years
Creating a score on clinical diagnosis	10 years
- Evaluation of individualized management: comparison between different management strategies on pain scores (analog visual scale), pregnancy-conception desire delay, live birth rate	10 years
Serum dosage of circulating antibodies before and after surgical treatment of lesions	10 years
Metabolic pathway exploration in adenomyosis lesions	10 years
Study of the presence of autoantibodies in cases of endometriosis and adenomyosis	10 years
Establish a genotype/phenotype correlation of the disease (endometriosis and adenomyosis)	10 years
To study the natural history of deep endometriosis lesions and analysis of focused invasion processes, epithelio-mesenchymatous transitions, and fibrogenesis using molecular biology techniques	10 years
Characterization of the microbiota in urine and vaginal samples.	10 years

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Louis Marcellin, MD, PhD, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2006
• Primary Completion (Anticipated): June 1, 2040
• Study Completion (Anticipated): December 1, 2040

Study Registration Dates

• First Submitted: July 17, 2020
• First Submitted That Met QC Criteria: July 17, 2020
• First Posted (Actual): July 22, 2020

Study Record Updates

• Last Update Posted (Actual): November 7, 2022
• Last Update Submitted That Met QC Criteria: November 4, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: pain; infertility; Endometriosis; Adenomyosis; disease progressiveness
• Additional Relevant MeSH Terms: Uterine Diseases; Endometriosis; Adenomyosis
• Other Study ID Numbers: NI18108

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No