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CompletedNCT02337816Updated Nov 6, 2018

Role of Metabolomics in the Diagnosis of Endometriosis

An observational study in Endometriosis, sponsored by University of Cagliari. Completed. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-11-06.

Sponsored by University of Cagliari · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
54
Ages
18 Years to 45 Years
Sex
Female
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Study 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

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Conditions studied

  • Endometriosis

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Keywords

  • Endometriosis
  • Metabolomics
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In context

Endometriosis

901 studies on the registry are indexed under Endometriosis; 259 are open to participants now.

This study's enrollment of 54 is below the median of 128 across 344 observational studies indexed under Endometriosis.

Browse Endometriosis studies →

Lead sponsor

University of Cagliari is the lead sponsor of 82 studies on the registry; 17 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Observational model
Case-control
Time perspective
Prospective
Enrollment
54 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

  • Procedurelaparoscopic surgery, obtainment of biological samples
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What researchers measure

Primary outcomes

  1. Plasma and urine concentration of metabolites

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

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 33174185 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 6, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02337816
Lead sponsor
University of Cagliari
Responsible party
Stefano Angioni (Associate Professor, University of Cagliari) — Principal investigator
First posted
Jan 14, 2015
Start date
Nov 2015
Primary completion
Jun 2016
Completion
Jun 2016
Last update
Nov 6, 2018

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.

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