Endometriosis and Brominated Flame Retardant (ENDOTOX Study)

NCT ID: NCT02651077

Last Updated: 2016-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

76 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-11-30

Study Completion Date

2014-11-30

Brief Summary

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The investigators wish to highlight, in a Case-Control design, if there is an increased concentration of BFRs in omental adipose tissue of cases ( women with severe endometriosis with surgical indication ) versus bioaccumulation recorded in a control cohort ( women recruited in obstetrics and gynecology or visceral surgery showing no sign of endometriosis ) . Pairing will be operate on Age (+/- 5 years compared to the case ) , BMI ( BMI 5 Classes described by the HAS) and previous breastfeeding experience (yes / no , opposite the release expected bioaccumulate contaminants in breast adipose tissue , when the lactation ) .

Detailed Description

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Conditions

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Endometriosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Case Group

38 women with severe and deep endometriosis, aged 18 to 45 years old and hospitalized at Nantes University Hospital for surgical indication of endometriosis lesions ablation.

No interventions assigned to this group

Control Group

38 women aged 18 to 45 years old without suggestive signs of endometriosis

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Age : 18-45 years old
* Deep endometriosis with or without endometriomas that need surgery (clinical examination, MRI, surgery)
* Accessing to the omental and/or parietal adipose tissue
* Non opposition of the patients for the samples collection and consent for the present study.

Inclusion criterion for the controls :

* Patients without any history of endometriosis and without suggestive symptomatology. Often patients operated for cesarean section.
* Possible access to the adipose tissue of the omentum or abdominal wall

Exclusion criterion for the cases :

* Pregnancy
* Death

Exclusion criterion for controls :

* Pregnancy
* Death
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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ONIRIS

INDUSTRY

Sponsor Role collaborator

Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stephane PLOTEAU, Dr

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Locations

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Nantes University Hospital

Nantes, , France

Site Status

Countries

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France

Other Identifiers

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RC13_0380

Identifier Type: -

Identifier Source: org_study_id

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