Brief Title
Clinical and Molecular Study of Endometriosis and Adenomyosis
Official Title
ENDOCHAP Monocentric Cohort: Clinical and Molecular Study of Endometriosis and Adenomyosis
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.
Study Type
Observational [Patient Registry]
Primary Outcome
Pain scores (analog visual scale), quantification of uterine bleeding (number of towels or tampon/day/month) and live birth rates
Secondary Outcome
Pain scores (analog visual scale), quantification of uterine bleeding (number of towels or tampon/day/month) and live birth rates
Condition
Endometriosis
Intervention
Biological/Vaccine
Study Arms / Comparison Groups
Patient with benign gynaecologic disease
Description: Patients consulting for endometriosis, pelvic pain, abnormal uterine bleeding and/or infertility, or for a pelvic mass,
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
5300
Start Date
May 2006
Completion Date
December 2040
Primary Completion Date
June 2040
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.
Gender
Female
Ages
18 Years - 42 Years
Contacts
Louis Marcellin, MD, PhD, 1 58 41 19 33, [email protected]
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT04481321
Organization ID
NI18108
Responsible Party
Sponsor
Study Sponsor
Assistance Publique - Hôpitaux de Paris
Study Sponsor
Louis Marcellin, MD, PhD, Principal Investigator, Assistance Publique - Hôpitaux de Paris
Verification Date
July 2020