Clinical trial NCT04481321: Clinical and Molecular Study of Endometriosis and Adenomyosis
Official title: ENDOCHAP Monocentric Cohort: Clinical and Molecular Study of Endometriosis and Adenomyosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Endometriosis
Adenomyosis
Keywords: Endometriosis
Adenomyosis
pain
infertility
disease progressiveness
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2020-07-22
Enrollment: 5300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain scores (analog visual scale), quantification of uterine bleeding (number of towels or tampon/day/month) and live birth rates
timeFrame: 10 years
measure: Changes in lesions or recurrences to imaging performed during the gynaecological follow-up of the patient
timeFrame: 10 years
Secondary outcomes:
measure: Pain scores (analog visual scale), quantification of uterine bleeding (number of towels or tampon/day/month) and live birth rates
timeFrame: 1 year
measure: Pain scores (analog visual scale), quantification of uterine bleeding (number of towels or tampon/day/month) and live birth rates
timeFrame: 3 years
measure: Pain scores (analog visual scale), quantification of uterine bleeding (number of towels or tampon/day/month) and live birth rates
timeFrame: 5 years
measure: Pain scores (analog visual scale), quantification of uterine bleeding (number of towels or tampon/day/month) and live birth rates
timeFrame: 7 years
measure: Delays between the onset of symptoms and post-operative or radiological histological diagnosis with specialized imaging (transvaginal ultrasound, endorectal ultrasound, magnetic resonance imagingI
timeFrame: 10 years
measure: meeting specific criteria for endometriosis and adenomyosis lesions
timeFrame: 10 years
measure: Association between clinical parameters of interrogation and clinical examination and the presence of endometriosis.
timeFrame: 10 years
measure: Association between clinical parameters of interrogation and clinical examination and the presence of adenomyosis.
timeFrame: 10 years
measure: Association between clinical data and the occurrence of the disease
timeFrame: 10 years
measure: Creating a score on clinical diagnosis
timeFrame: 10 years
measure: - Evaluation of individualized management: comparison between different management strategies on pain scores (analog visual scale), pregnancy-conception desire delay, live birth rate
timeFrame: 10 years
measure: Serum dosage of circulating antibodies before and after surgical treatment of lesions
timeFrame: 10 years
measure: Metabolic pathway exploration in adenomyosis lesions
timeFrame: 10 years
measure: Study of the presence of autoantibodies in cases of endometriosis and adenomyosis
timeFrame: 10 years
measure: Establish a genotype/phenotype correlation of the disease (endometriosis and adenomyosis)
timeFrame: 10 years
measure: To study the natural history of deep endometriosis lesions and analysis of focused invasion processes, epithelio-mesenchymatous transitions, and fibrogenesis using molecular biology techniques
timeFrame: 10 years
measure: Characterization of the microbiota in urine and vaginal samples.
timeFrame: 10 years
Other outcomes:
Locations:
city: Paris
country: France
facility: Port Royal, hospital cochin
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Louis Marcellin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: