Endometriosis and Brominated Flame Retardant (ENDOTOX Study)

NCT02651077 | Completed

• 1 other identifier: RC13_0380
• Study Type: observational
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

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 ) .

Conditions

Endometriosis

Keywords

Endometriosis, chemical contaminants, BFRs

Outcome Measures

Primary Outcomes (1)

• Concentrations of brominated flame retardant (BFR) in adipose tissue and serum

  baseline

Secondary Outcomes (3)

• Concentrations of dioxins in adipose tissue and serum

  baseline

• Concentrations of polychlorinated biphenyls (PCBs),

  baseline

• Concentrations of organochlorine pesticides (OCPs) in adipose tissue and serum

  baseline

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Nantes University Hospital: lead
• ONIRIS: collaborator

Study Sites (1)

Nantes University Hospital

Nantes, 44093, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

omental adipose tissue

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Stephane PLOTEAU, Dr

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2016
• First Posted: January 8, 2016
• Study Start: November 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: January 8, 2016

Record last verified: 2016-01

Locations

FR (1)