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NCT02337816 Clinical Trial

Role of Metabolomics in the Diagnosis of Endometriosis

Endometriosis Clinical Trial

Official title:
Role of Metabolomics in the Diagnosis of Endometriosis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02337816
Other study ID # ENDOMETAB01
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 2015
Est. completion date June 2016

Study information
Verified date November 2018
Source University of Cagliari
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Endometriosis is one of the most common benign gynecological, affecting about 10% of premenopausal women. The pathophysiology of this disease is still not completely clear. Despite its prevalence, there is no blood test available for the diagnosis of endometriosis and the average delay time to diagnosis is 9.4 years.

Metabolomics is a scientific discipline that studies changes in metabolites related to the pathophysiology of the disease.

Aim of the study is to identify an alteration in the expression of the metabolites in women with endometriosis

Recruitment information / eligibility
Status Completed
Enrollment 54
Est. completion date June 2016
Est. primary completion date June 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- women of childbearing age ;

- written consent to laparoscopic surgery;

- written consent to the study .

Exclusion Criteria:

- Suspicion or diagnosis of malignant disease

- Inability or unwillingness to provide written consent

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• laparoscopic surgery, obtainment of biological samples

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University of Cagliari

Outcome
Type Measure Description Time frame Safety issue
Primary Plasma and urine concentration of metabolites At least one month after discontinuation of hormonal therapies , before laparoscopic surgery
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