EndometriosisNCT06426420
Endometriosis and ATR-FTIR Spectroscopy
A study testing FTIR spectroscopy analysis in people with Endometriosis and Endometriomas, run by Federal University of Espirito Santo at 1 site in Brazil.
Trial summary
The goal of this study is to explore the use of mid-infrared spectroscopy (ATR-FTIR) as a detection tool for endometriosis in urine. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Endometriosis, Endometriomas
- What is being tested?
- FTIR spectroscopy analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteBrazil
- Study dates
- 15 Sep 2022to 29 Apr 2026
- Phase
- Interventional
- 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 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female
- Pelvic pain complain
Who cannot join
- Age under 18 or above 55
- Lack of informed consent
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
University Hospital Cassiano Antonio Moraes at Federal Univeristy Of Espírito Santo
Vitória, Espírito Santo, 29041-295
Neide A Boldrini, phD, +552733357100, neide.boldrini@ebserh.gov.br
Mara RB Barcelos, phD, +5527999829511, mararsb@gmail.com
About this study
Official title: Detection of Endometriosis Using ATR-FTIR Spectroscopy
The goal of this study is to explore the use of mid-infrared spectroscopy (ATR-FTIR) as a detection tool for endometriosis in urine.
Read the detailed description
Endometriosis is a chronic gynecological disease that is considered debilitating and multifactorial. Its diagnosis is invasive and can be prolonged due to non-specific symptoms and erroneous or late investigations, which can lead to delays and impair the provision of adequate treatment.
ATR-FTIR Spectroscopy is a non-invasive technique with the capability to identify the chemical composition and molecular changes of samples through its interaction with mid-infrared radiation. The aim of this work is to develop a rapid test for the detection of endometriosis in urine samples using spectroscopy and machine learning algorithms.
- Conditions
- Endometriosis, Endometriomas
- Being tested
- FTIR spectroscopy analysis
- Keywords
- Endometriosis, Diagnosis, Spectroscopy, FTIR, Urine, Detection, Infrared
- Medical subject headings
- Endometriosis, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FTIR spectroscopy analysisDiagnostic test
ATR-FTIR Spectroscopy analysis combined with machine learning algorithms.
| Study group | Role | What they receive |
|---|---|---|
| Pelvic Pain | Experimental | Patients referred to the gynecology outpatient clinic, with complain of pelvic pain. Positives and negatives for endometriosis will be outlined by an expert gynecologist according to the following criteria:
* Pelvic MRI (Magnetic Resonance Imaging) report;
* Gynecologic exam;
* Clinical symptoms and history;
The intervention is the use of the ATR-FTIR Spectrometer in patient's urine samples to develop and validate a tool for detecting endometriosis. Receives: Diagnostic Test: FTIR spectroscopy analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spectroscopy Reliability (diagnostic metrics)
The primary outcome is the evaluation of specificity, sensitivity and accuracy of the diagnostic. Acceptable diagnostic metrics must be comparable to MRI, which will demonstrate if spectroscopy can discriminate between negative and positive endometriosis patients.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2024
- Study start15 Sep 2022
- Primary completion29 Apr 2026 (estimated)
- Study completion29 Apr 2026 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Espirito Santo
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Principal investigator, VALERIO GARRONE BARAUNA, Federal University of Espirito Santo
- Investigators
- Valerio G Barauna, PhD, Principal investigator, Universidade Federal do Espírito Santo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06426420
- Sponsor's protocol ID
- FTIR-ENDOMETRIOSIS
- Status last verified
- May 2024
- First submitted
- 14 May 2024
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Martins MS, Valente GB, Pedra YDN, Ribeiro TC, Boldrini NAT, Barcelos MRB, Martin FL, Rossi KKC, Barauna VG. A machine learning approach towards endometriosis screening using infrared spectra of urine. Clinics (Sao Paulo). 2025 Jan-Dec;80:100760. doi: 10.1016/j.clinsp.2025.100760. Epub 2025 Sep 6.
PubMed 40915181
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Endometriosis Using ATR-FTIR Spectroscopy
- ClinicalTrials.gov ID
- NCT06426420
- Acronym / sponsor ID
- FTIR-ENDOMETRIOSIS
- Conditions
- Endometriosis, Endometriomas
- Keywords
- Endometriosis, Diagnosis, Spectroscopy, FTIR, Urine, Detection, Infrared
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Federal University of Espirito SantoUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 29 Apr 2026 (estimated)
- Study completion
- 29 Apr 2026 (estimated)
- First posted
- 23 May 2024 (actual)
- 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.
The goal of this study is to explore the use of mid-infrared spectroscopy (ATR-FTIR) as a detection tool for endometriosis in urine.
Detailed description
Endometriosis is a chronic gynecological disease that is considered debilitating and multifactorial. Its diagnosis is invasive and can be prolonged due to non-specific symptoms and erroneous or late investigations, which can lead to delays and impair the provision of adequate treatment.
ATR-FTIR Spectroscopy is a non-invasive technique with the capability to identify the chemical composition and molecular changes of samples through its interaction with mid-infrared radiation. The aim of this work is to develop a rapid test for the detection of endometriosis in urine samples using spectroscopy and machine learning algorithms.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pelvic Pain | Experimental | Diagnostic Test: FTIR spectroscopy analysisPatients referred to the gynecology outpatient clinic, with complain of pelvic pain. Positives and negatives for endometriosis will be outlined by an expert gynecologist according to the following criteria: * Pelvic MRI (Magnetic Resonance Imaging) report; * Gynecologic exam; * Clinical symptoms and history; The intervention is the use of the ATR-FTIR Spectrometer in patient's urine samples to develop and validate a tool for detecting endometriosis. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Female
- Pelvic pain complain
Key exclusion criteria (2 listed)
- Age under 18 or above 55
- Lack of informed 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 |
|---|---|---|
| FTIR spectroscopy analysisATR-FTIR Spectroscopy analysis combined with machine learning algorithms. | Diagnostic test | Pelvic Pain |
Primary outcome
Spectroscopy Reliability (diagnostic metrics)
Time frame: 1 year
The primary outcome is the evaluation of specificity, sensitivity and accuracy of the diagnostic. Acceptable diagnostic metrics must be comparable to MRI, which will demonstrate if spectroscopy can discriminate between negative and positive endometriosis patients.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
- Derived from this study: PubMed 40915181Martins MS, Valente GB, Pedra YDN, Ribeiro TC, Boldrini NAT, Barcelos MRB, Martin FL, Rossi KKC, Barauna VG. A machine learning approach towards endometriosis screening using infrared spectra of urine. Clinics (Sao Paulo). 2025 Jan-Dec;80:100760. doi: 10.1016/j.clinsp.2025.100760. Epub 2025 Sep 6.
- Individual participant dataSharing planned: No
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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.
Valerio G Barauna, PhD principal investigator
Universidade Federal do Espírito Santo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FTIR spectroscopy analysis in people with Endometriosis and Endometriomas, run by Federal University of Espirito Santo at 1 site in Brazil.
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 2 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: status not confirmed, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Valerio G Barauna, PhD (+5527996892407, barauna2@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spectroscopy Reliability (diagnostic metrics) (time frame: 1 year). 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 NCT06426420, 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 29 May 2024.