Overview

This trial is active, not recruiting.

Condition endometriosis
Treatment laparoscopic surgery, obtainment of biological samples
Sponsor University of Cagliari
Start date December 2014
End date March 2016
Trial size 40 participants
Trial identifier NCT02337816, ENDOMETAB01

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Other)
Patients will undergo laparoscopic surgery in order to treat endometriosis. Biopsies will be performed for histological confirmation of the disease. Samples of urine and blood, with the purpose to study metabolitis, will be collected before surgery.
laparoscopic surgery, obtainment of biological samples
(Other)
Patients will undergo laparoscopic surgery in order to treat benign gynecological diseases. Biopsies will be performed for histological confirmation of the disease. Samples of urine and blood,with the purpose to study metabolitis, will be collected before surgery.
laparoscopic surgery, obtainment of biological samples

Primary Outcomes

Measure
Plasma and urine concentration of metabolites
time frame: At least one month after discontinuation of hormonal therapies , before laparoscopic surgery

Eligibility Criteria

Female participants from 18 years up to 45 years old.

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

Additional Information

Official title Role of Metabolomics in the Diagnosis of Endometriosis
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by University of Cagliari.