ENDOCHAP: Clinical and Molecular Study of Endometriosis and Adenomyosis
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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 Design
Arms and Interventions
| Arm | 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:
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Outcome Measures
Primary Outcome Measures
- Pain scores (analog visual scale), quantification of uterine bleeding (number of towels or tampon/day/month) and live birth rates [10 years]
Composite outcome
- Changes in lesions or recurrences to imaging performed during the gynaecological follow-up of the patient [10 years]
Secondary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Women of age between - 18 and 42 years old.
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In-service care for one of the pelvic pain and/or infertility, or for a pelvic mass.
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Having a radiological diagnosis made by a referral practitioner and/or operated in the department
Exclusion Criteria:
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HIV-positive women, HBV and HCV
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During pregnancy
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Having a cancer diagnosis
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Refusing to sign a consent.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Port Royal, hospital cochin | Paris | France | 75014 |
Sponsors and Collaborators
- Assistance Publique - Hôpitaux de Paris
Investigators
- Principal Investigator: Louis Marcellin, MD, PhD, Assistance Publique - Hôpitaux de Paris
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NI18108