## Protocol Section
### Identification Module
**NCT ID:** NCT06426420

**Brief Title:** Endometriosis and ATR-FTIR Spectroscopy

**Official Title:** Detection of Endometriosis Using ATR-FTIR Spectroscopy

#### Organization Study ID Info
**ID:** FTIR-ENDOMETRIOSIS
#### Organization
**Class:** OTHER
**Full Name:** Federal University of Espirito Santo
### Status Module
#### Completion Date
**Date:** 2026-04-29

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-26

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2026-04-29

**Type:** ESTIMATED

#### Start Date
**Date:** 2022-09-15

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER_GOV

**Name:** Conselho Nacional de Desenvolvimento Científico e Tecnológico

#### Lead Sponsor

**Class:** OTHER

**Name:** Federal University of Espirito Santo

#### Responsible Party

**Investigator Affiliation:** Federal University of Espirito Santo

**Investigator Full Name:** VALERIO GARRONE BARAUNA

**Investigator Title:** Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

**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 Module

**Conditions:**

- Endometriosis

- Endometriomas

**Keywords:**

- Endometriosis

- Diagnosis

- Spectroscopy

- FTIR

- Urine

- Detection

- Infrared

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** DIAGNOSTIC

#### Enrollment Info

**Count:** 600

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Diagnostic Test: FTIR spectroscopy analysis

**Label:** Pelvic Pain

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Pelvic Pain

**Description:** ATR-FTIR Spectroscopy analysis combined with machine learning algorithms.

**Name:** FTIR spectroscopy analysis

**Type:** DIAGNOSTIC_TEST

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Spectroscopy Reliability (diagnostic metrics)

**Time Frame:** 1 year

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Female
* Pelvic pain complain

Exclusion Criteria:

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

**Gender Based:** True

**Gender Description:** Biological woman self-identified as woman

**Maximum Age:** 55 Years

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** barauna2@gmail.com

**Name:** Valerio G Barauna, PhD

**Phone:** +5527996892407

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Vitória

**Contacts:**

***Contact 1:***

- **Email:** neide.boldrini@ebserh.gov.br

- **Name:** Neide A Boldrini, phD

- **Phone:** +552733357100

- **Role:** CONTACT

***Contact 2:***

- **Email:** mararsb@gmail.com

- **Name:** Mara RB Barcelos, phD

- **Phone:** +5527999829511

- **Role:** CONTACT

***Contact 3:***

- **Name:** Neide A Boldrini, phD

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 4:***

- **Name:** Mara RB Barcelos, phD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Brazil

**Facility:** University Hospital Cassiano Antonio Moraes at Federal Univeristy Of Espírito Santo

**State:** Espírito Santo

**Status:** RECRUITING

**Zip:** 29041-295

#### Overall Officials

**Official 1:**

**Affiliation:** Universidade Federal do Espírito Santo

**Name:** Valerio G Barauna, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000005831

- Term: Genital Diseases, Female

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000091662

- Term: Genital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M7877

- Name: Endometriosis

- Relevance: HIGH

- As Found: Endometriosis

- ID: M8943

- Name: Genital Diseases, Female

- Relevance: LOW

- As Found: Unknown

- ID: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000004715

- Term: Endometriosis

### Misc Info Module

- Version Holder: 2024-05-31
