Endometriosis and Brominated Flame Retardant (ENDOTOX Study) (ENDOTOX)

January 7, 2016 updated by: Nantes University Hospital

Looking for a Link Between Endometriosis and Exposure to Lipophilic Environmental Chemicals Like Brominated Flame Retardant (ENDOTOX Study)

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 ) .

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

76

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nantes, France, 44093
        • Nantes University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

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.

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

Description

Inclusion criterion for de cases :

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.
Control Group
38 women aged 18 to 45 years old without suggestive signs of endometriosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Concentrations of brominated flame retardant (BFR) in adipose tissue and serum
Time Frame: baseline
baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
Concentrations of dioxins in adipose tissue and serum
Time Frame: baseline
baseline
Concentrations of polychlorinated biphenyls (PCBs),
Time Frame: baseline
baseline
Concentrations of organochlorine pesticides (OCPs) in adipose tissue and serum
Time Frame: baseline
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Collaborators

ONIRIS

Investigators

  • Principal Investigator: Stephane PLOTEAU, Dr, Nantes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

January 6, 2016

First Submitted That Met QC Criteria

January 7, 2016

First Posted (Estimate)

January 8, 2016

Study Record Updates

Last Update Posted (Estimate)

January 8, 2016

Last Update Submitted That Met QC Criteria

January 7, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC13_0380

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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