Ignite Creation Date:
2025-12-25 @ 4:09 AM
Ignite Modification Date:
2026-01-16 @ 5:26 PM
Study NCT ID:
NCT06426420
Status:
RECRUITING
Last Update Posted:
2024-05-29
First Post:
2024-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endometriosis and ATR-FTIR Spectroscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004715', 'term': 'Endometriosis'}, {'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2026-04-29', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-26', 'studyFirstSubmitDate': '2024-05-14', 'studyFirstSubmitQcDate': '2024-05-17', 'lastUpdatePostDateStruct': {'date': '2024-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Spectroscopy Reliability (diagnostic metrics)', 'timeFrame': '1 year', '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Endometriosis', 'Diagnosis', 'Spectroscopy', 'FTIR', 'Urine', 'Detection', 'Infrared'], 'conditions': ['Endometriosis', 'Endometriomas']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to explore the use of mid-infrared spectroscopy (ATR-FTIR) as a detection tool for endometriosis in urine.', 'detailedDescription': '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.\n\nATR-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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Biological woman self-identified as woman', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female\n* Pelvic pain complain\n\nExclusion Criteria:\n\n* Age under 18 or above 55\n* Lack of informed consent'}, 'identificationModule': {'nctId': 'NCT06426420', 'briefTitle': 'Endometriosis and ATR-FTIR Spectroscopy', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of Espirito Santo'}, 'officialTitle': 'Detection of Endometriosis Using ATR-FTIR Spectroscopy', 'orgStudyIdInfo': {'id': 'FTIR-ENDOMETRIOSIS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pelvic Pain', '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:\n\n* Pelvic MRI (Magnetic Resonance Imaging) report;\n* Gynecologic exam;\n* Clinical symptoms and history;\n\nThe intervention is the use of the ATR-FTIR Spectrometer in patient's urine samples to develop and validate a tool for detecting endometriosis.", 'interventionNames': ['Diagnostic Test: FTIR spectroscopy analysis']}], 'interventions': [{'name': 'FTIR spectroscopy analysis', 'type': 'DIAGNOSTIC_TEST', 'description': 'ATR-FTIR Spectroscopy analysis combined with machine learning algorithms.', 'armGroupLabels': ['Pelvic Pain']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29041-295', 'city': 'Vitória', 'state': 'Espírito Santo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Neide A Boldrini, phD', 'role': 'CONTACT', 'email': 'neide.boldrini@ebserh.gov.br', 'phone': '+552733357100'}, {'name': 'Mara RB Barcelos, phD', 'role': 'CONTACT', 'email': 'mararsb@gmail.com', 'phone': '+5527999829511'}, {'name': 'Neide A Boldrini, phD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Mara RB Barcelos, phD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospital Cassiano Antonio Moraes at Federal Univeristy Of Espírito Santo', 'geoPoint': {'lat': -20.31944, 'lon': -40.33778}}], 'centralContacts': [{'name': 'Valerio G Barauna, PhD', 'role': 'CONTACT', 'email': 'barauna2@gmail.com', 'phone': '+5527996892407'}], 'overallOfficials': [{'name': 'Valerio G Barauna, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidade Federal do Espírito Santo'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of Espirito Santo', 'class': 'OTHER'}, 'collaborators': [{'name': 'Conselho Nacional de Desenvolvimento Científico e Tecnológico', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'VALERIO GARRONE BARAUNA', 'investigatorAffiliation': 'Federal University of Espirito Santo'}}}}