Endometriosis and ATR-FTIR Spectroscopy

NCT06426420 | Recruiting

• 1 other identifier: FTIR-ENDOMETRIOSIS
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Endometriosis; Endometriomas

Keywords

Endometriosis; Diagnosis; Spectroscopy; FTIR; Urine; Detection; Infrared

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Study Arms (1)

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.

Diagnostic Test: FTIR spectroscopy analysis

Interventions

FTIR spectroscopy analysis DIAGNOSTIC_TEST

ATR-FTIR Spectroscopy analysis combined with machine learning algorithms.

Pelvic Pain

Eligibility Criteria

• Age: 18 Years - 55 Years
• Gender Eligibility Details: Biological woman self-identified as woman
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female
• Pelvic pain complain

You may not qualify if:

• Age under 18 or above 55
• Lack of informed consent

Sponsors & Collaborators

• Federal University of Espirito Santo: lead
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (1)

University Hospital Cassiano Antonio Moraes at Federal Univeristy Of Espírito Santo

Vitória, Espírito Santo, 29041-295, Brazil

RECRUITING

MeSH Terms

Conditions

Endometriosis; Disease

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Valerio G Barauna, PhD

  Universidade Federal do Espírito Santo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Valerio G Barauna, PhD

CONTACT

+5527996892407; barauna2@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 14, 2024
• First Posted: May 23, 2024
• Study Start: September 15, 2022
• Primary Completion: April 29, 2026
• Study Completion: April 29, 2026
• Last Updated: May 29, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)