EndometriosisNCT02337816
Role of Metabolomics in the Diagnosis of Endometriosis
An observational study of Endometriosis, run by University of Cagliari.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometriosis
- What is being tested?
- laparoscopic surgery, obtainment of biological samples
- Type of treatment
- Surgery or procedure
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: women of childbearing age , patients of the University Hospital , suffering from benign gynecological disease
Who may be able to join
- women of childbearing age ;
- written consent to laparoscopic surgery;
- written consent to the study .
Who cannot join
- Suspicion or diagnosis of malignant disease
- Inability or unwillingness to provide written consent
About this study
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
- Being tested
- laparoscopic surgery, obtainment of biological samples
- Keywords
- Endometriosis, Metabolomics
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic surgery, obtainment of biological samplesProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: laparoscopic surgery, obtainment of biological samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma and urine concentration of metabolites
Measured: At least one month after discontinuation of hormonal therapies , before laparoscopic surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2015 (estimated)
- Study startNov 2015
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cagliari
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefano Angioni, University of Cagliari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02337816
- Sponsor's protocol ID
- ENDOMETAB01
- Status last verified
- Nov 2018
- First submitted
- 9 Jan 2015
- Last updated
- 6 Nov 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Metabolomics in the Diagnosis of Endometriosis
- ClinicalTrials.gov ID
- NCT02337816
- Acronym / sponsor ID
- ENDOMETAB01
- Conditions
- Endometriosis
- Keywords
- Endometriosis, Metabolomics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of CagliariUniversity, hospital or other
- Study start
- Nov 2015 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 14 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endometriosis | – | Procedure: laparoscopic surgery, obtainment of biological samplesPatients 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. |
| Controls | – | Procedure: laparoscopic surgery, obtainment of biological samplesPatients 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- women of childbearing age , patients of the University Hospital , suffering from benign gynecological disease
Key inclusion criteria (3 listed)
- women of childbearing age ;
- written consent to laparoscopic surgery;
- written consent to the study .
Key exclusion criteria (2 listed)
- Suspicion or diagnosis of malignant disease
- Inability or unwillingness to provide written consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laparoscopic surgery, obtainment of biological samples | Procedure or surgery | Controls, Endometriosis |
Primary outcome
Plasma and urine concentration of metabolites
Time frame: At least one month after discontinuation of hormonal therapies , before laparoscopic surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2018.
- Derived from this study: PubMed 33174185Murgia 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis, run by University of Cagliari.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma and urine concentration of metabolites (time frame: At least one month after discontinuation of hormonal therapies , before laparoscopic surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02337816, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2018.