Endometriosis and Brominated Flame Retardant (ENDOTOX Study)

Endometriosis Clinical Trial

— ENDOTOX  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02651077
• Other study ID #: RC13_0380
• Status: Completed
• Phase: N/A
• First received: January 6, 2016
• Last updated: January 7, 2016
• Start date: November 2013
• Est. completion date: November 2014

Study information

• Verified date: January 2016
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Commission nationale de l'informatique et des libertés
• Study type: Observational

Clinical Trial 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 ) .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Endometriosis

Locations

Country	Name	City	State
France	Nantes University Hospital	Nantes

Sponsors (2)

Lead Sponsor	Collaborator
Nantes University Hospital	ONIRIS

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentrations of brominated flame retardant (BFR) in adipose tissue and serum		baseline	No
Secondary	Concentrations of dioxins in adipose tissue and serum		baseline	No
Secondary	Concentrations of polychlorinated biphenyls (PCBs),		baseline	No
Secondary	Concentrations of organochlorine pesticides (OCPs) in adipose tissue and serum		baseline	No