Role of Metabolomics in the Diagnosis of Endometriosis

NCT ID: NCT02337816

Last Updated: 2018-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

54 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-11-30

Study Completion Date

2016-06-30

Brief Summary

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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

Detailed Description

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Conditions

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Endometriosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

laparoscopic surgery, obtainment of biological samples

Intervention Type PROCEDURE

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.

laparoscopic surgery, obtainment of biological samples

Intervention Type PROCEDURE

Interventions

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laparoscopic surgery, obtainment of biological samples

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Cagliari

OTHER

Sponsor Role lead

Responsible Party

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Stefano Angioni

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type DERIVED
PMID: 33174185 (View on PubMed)

Other Identifiers

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ENDOMETAB01

Identifier Type: -

Identifier Source: org_study_id

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