Role of Metabolomics in the Diagnosis of Endometriosis

NCT02337816 | Completed

• 1 other identifier: ENDOMETAB01
• Study Type: observational
• Target: 54
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Endometriosis

Keywords

Endometriosis; Metabolomics

Outcome Measures

Primary Outcomes (1)

• Plasma and urine concentration of metabolites

  At least one month after discontinuation of hormonal therapies , before laparoscopic surgery

Study Arms (2)

Endometriosis

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.

Procedure: laparoscopic surgery, obtainment of biological samples

Controls

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.

Procedure: laparoscopic surgery, obtainment of biological samples

Interventions

laparoscopic surgery, obtainment of biological samples PROCEDURE

Controls; Endometriosis

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

women of childbearing age , patients of the University Hospital , suffering from benign gynecological disease

You may qualify if:

• women of childbearing age ;
• written consent to laparoscopic surgery;
• written consent to the study .

You may not qualify if:

• Suspicion or diagnosis of malignant disease
• Inability or unwillingness to provide written consent

Sponsors & Collaborators

• University of Cagliari: lead

Related Publications (1)

• Murgia F, Angioni S, D'Alterio MN, Pirarba S, Noto A, Santoru ML, Tronci L, Fanos V, Atzori L, Congiu F. Metabolic Profile of Patients with Severe Endometriosis: a Prospective Experimental Study. Reprod Sci. 2021 Mar;28(3):728-735. doi: 10.1007/s43032-020-00370-9. Epub 2020 Nov 10.

  PMID: 33174185 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

urine samples, blood samples

MeSH Terms

Conditions

Endometriosis

Interventions

Laparoscopy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 9, 2015
• First Posted: January 14, 2015
• Study Start: November 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: November 6, 2018

Record last verified: 2018-11