Clinical and Molecular Study of Endometriosis and Adenomyosis

Endometriosis Clinical Trial

— ENDOCHAP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04481321
• Other study ID #: NI18108
• Status: Recruiting
• Start date: May 2006
• Est. completion date: December 2040

Study information

• Verified date: November 2022
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Charles Chapron, MD
• Phone: 1 58 41 19 33
• Email: charles.chapron[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5300
• Est. completion date: December 2040
• Est. primary completion date: June 2040
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adenomyosis
• Endometriosis

Intervention

Biological:
• Biological/Vaccine

Locations

Country	Name	City	State
France	Port Royal, hospital cochin	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain scores (analog visual scale), quantification of uterine bleeding (number of towels or tampon/day/month) and live birth rates	Composite outcome	10 years
Primary	Changes in lesions or recurrences to imaging performed during the gynaecological follow-up of the patient		10 years
Secondary	Pain scores (analog visual scale), quantification of uterine bleeding (number of towels or tampon/day/month) and live birth rates		1 year
Secondary	Pain scores (analog visual scale), quantification of uterine bleeding (number of towels or tampon/day/month) and live birth rates		3 years
Secondary	Pain scores (analog visual scale), quantification of uterine bleeding (number of towels or tampon/day/month) and live birth rates		5 years
Secondary	Pain scores (analog visual scale), quantification of uterine bleeding (number of towels or tampon/day/month) and live birth rates		7 years
Secondary	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
Secondary	meeting specific criteria for endometriosis and adenomyosis lesions		10 years
Secondary	Association between clinical parameters of interrogation and clinical examination and the presence of endometriosis.		10 years
Secondary	Association between clinical parameters of interrogation and clinical examination and the presence of adenomyosis.		10 years
Secondary	Association between clinical data and the occurrence of the disease		10 years
Secondary	Creating a score on clinical diagnosis		10 years
Secondary	- Evaluation of individualized management: comparison between different management strategies on pain scores (analog visual scale), pregnancy-conception desire delay, live birth rate		10 years
Secondary	Serum dosage of circulating antibodies before and after surgical treatment of lesions		10 years
Secondary	Metabolic pathway exploration in adenomyosis lesions		10 years
Secondary	Study of the presence of autoantibodies in cases of endometriosis and adenomyosis		10 years
Secondary	Establish a genotype/phenotype correlation of the disease (endometriosis and adenomyosis)		10 years
Secondary	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
Secondary	Characterization of the microbiota in urine and vaginal samples.		10 years