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Clinical and Molecular Study of Endometriosis and Adenomyosis (ENDOCHAP)

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ClinicalTrials.gov Identifier: NCT04481321
Recruitment Status : Recruiting
First Posted : July 22, 2020
Last Update Posted : July 22, 2020
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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
Endometriosis Adenomyosis 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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 5300 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: ENDOCHAP Monocentric Cohort: Clinical and Molecular Study of Endometriosis and Adenomyosis
Actual Study Start Date : May 2006
Estimated Primary Completion Date : June 2040
Estimated Study Completion Date : December 2040

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis

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




Primary Outcome Measures :
  1. Pain scores (analog visual scale), quantification of uterine bleeding (number of towels or tampon/day/month) and live birth rates [ Time Frame: 10 years ]
    Composite outcome

  2. Changes in lesions or recurrences to imaging performed during the gynaecological follow-up of the patient [ Time Frame: 10 years ]

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

Biospecimen Retention:   Samples With DNA
Peripheral blood, Vaginal and urinary swab, Endometriosis lesions,endometrial biopsies, Myometer biopsies, Peritoneal fluid, Follicular fluid biopsies


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Ages Eligible for Study:   18 Years to 42 Years   (Adult)
Sexes 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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04481321


Contacts
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Contact: Charles Chapron, MD 1 58 41 19 33 ext +33 charles.chapron@aphp.fr
Contact: Laurence Lecomte, PhD 1 58 41 34 78 ext +33 laurence.lecomte@aphp.fr

Locations
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France
Port Royal, hospital cochin Recruiting
Paris, France, 75014
Contact: Louis Marcellin, MD, PhD    1 58415495 ext +33    louis.marcellin@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Louis Marcellin, MD, PhD Assistance Publique - Hôpitaux de Paris
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04481321    
Other Study ID Numbers: NI18108
First Posted: July 22, 2020    Key Record Dates
Last Update Posted: July 22, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Endometriosis
Adenomyosis
pain
infertility
disease progressiveness
Additional relevant MeSH terms:
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Endometriosis
Adenomyosis
Genital Diseases, Female
Uterine Diseases