Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-26 @ 1:11 AM
Study NCT ID:
NCT03468634
Status:
COMPLETED
Last Update Posted:
2024-04-25
First Post:
2018-01-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Raman Probe for In-vivo Diagnostics (During Oesophageal) Endoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001471', 'term': 'Barrett Esophagus'}, {'id': 'D004938', 'term': 'Esophageal Neoplasms'}], 'ancestors': [{'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D016145', 'term': 'Endoscopy, Digestive System'}], 'ancestors': [{'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D003938', 'term': 'Diagnostic Techniques, Digestive System'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-04-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-24', 'studyFirstSubmitDate': '2018-01-11', 'studyFirstSubmitQcDate': '2018-03-15', 'lastUpdatePostDateStruct': {'date': '2024-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Device safety testing (no detectable damage in biopsy samples when reviewed by histopathology)', 'timeFrame': '6 months', 'description': 'Testing of the device for clinical application to demonstrate its use is safe and that is able to acquire diagnostic-quality (see outcome 2) spectra in less than 5 seconds from within the oesophagus.\n\nSamples illuminated will be biopsied and sent for routine histopathological analysis.'}], 'secondaryOutcomes': [{'measure': 'Diagnostic model developed (algorithm able to discriminate disease with >50% specificity and >50% sensitivity)', 'timeFrame': '6 months', 'description': 'Computer model using multivariate analysis able to discriminate between diseased and non-diseased tissue. The target specificity and sensitivity are low due to small study group sizes.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['endoscopy', 'Raman spectroscopy'], 'conditions': ['Barrett Esophagus', 'Esophageal Cancer']}, 'referencesModule': {'references': [{'pmid': '27048868', 'type': 'BACKGROUND', 'citation': 'Isabelle M, Dorney J, Lewis A, Lloyd GR, Old O, Shepherd N, Rodriguez-Justo M, Barr H, Lau K, Bell I, Ohrel S, Thomas G, Stone N, Kendall C. Multi-centre Raman spectral mapping of oesophageal cancer tissues: a study to assess system transferability. Faraday Discuss. 2016 Jun 23;187:87-103. doi: 10.1039/c5fd00183h.'}, {'pmid': '12898596', 'type': 'BACKGROUND', 'citation': "Kendall C, Stone N, Shepherd N, Geboes K, Warren B, Bennett R, Barr H. Raman spectroscopy, a potential tool for the objective identification and classification of neoplasia in Barrett's oesophagus. J Pathol. 2003 Aug;200(5):602-9. doi: 10.1002/path.1376."}], 'seeAlsoLinks': [{'url': 'https://rapide-diagnostics.co.uk/', 'label': 'RaPIDE project website'}]}, 'descriptionModule': {'briefSummary': 'To develop and endoscopic Raman spectroscopy probe for delivery down and channel in an endoscope to make near instant assessments of the condition of the oesophagus without the need for expensive and distressing tissue removal (biopsies).', 'detailedDescription': 'The investigators have already shown that it is possible to tell the difference between healthy and diseased tissue in the laboratory by looking at the light emitted by tissue when illuminated with a low power laser. The investigators intend to use this technique, known as "Raman Spectroscopy" to tell if tissue in the oesophagus is cancerous, healthy or at some stage before full blown cancer, which is termed pre-cancer. It has been shown in the laboratory that this method will be at least as accurate as the conventional methods used now, but will provide the surgeon with instant results without the delay and cost of a laboratory analysis by pathologists.\n\nA miniature probe has been developed that slides through a channel in the endoscope (telescope) to the surface of the oesophagus to make near instant assessments of its condition without the need for expensive and distressing tissue removal (biopsies). This project plans to move this technique from the laboratory to the clinic by demonstrating that the method is safe and reliable for use in real patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Barrett's oesophagus\n\nExclusion Criteria:\n\n* Unfit for endoscopic and biopsy assessment"}, 'identificationModule': {'nctId': 'NCT03468634', 'acronym': 'RaPIDE', 'briefTitle': 'Raman Probe for In-vivo Diagnostics (During Oesophageal) Endoscopy', 'organization': {'class': 'OTHER', 'fullName': 'University of Exeter'}, 'officialTitle': 'Raman Probe for In-vivo Diagnostics (During Oesophageal) Endoscopy', 'orgStudyIdInfo': {'id': '1516/017/162347'}, 'secondaryIdInfos': [{'id': 'II-LB-0315-20008', 'type': 'OTHER_GRANT', 'domain': 'NIHR'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Adenocarcinoma', 'description': 'patients diagnosed with adenocarcinoma', 'interventionNames': ['Diagnostic Test: endoscopy']}, {'type': 'EXPERIMENTAL', 'label': 'Squamous cell cancer', 'description': 'patients diagnosed with squamous cell cancer', 'interventionNames': ['Diagnostic Test: endoscopy']}, {'type': 'EXPERIMENTAL', 'label': 'Other', 'description': 'patients diagnosed with another condition', 'interventionNames': ['Diagnostic Test: endoscopy']}, {'type': 'EXPERIMENTAL', 'label': "Barrett's oesophagus", 'description': "patients diagnosed with Barrett's oesophagus", 'interventionNames': ['Diagnostic Test: endoscopy']}, {'type': 'EXPERIMENTAL', 'label': 'Low-grade dysplasia', 'description': 'patients diagnosed with low-grade dysplasia', 'interventionNames': ['Diagnostic Test: endoscopy']}, {'type': 'EXPERIMENTAL', 'label': 'High-grade dysplasia', 'description': 'patients diagnosed with high-grade dysplasia', 'interventionNames': ['Diagnostic Test: endoscopy']}, {'type': 'EXPERIMENTAL', 'label': 'Indefinite for dysplasia', 'description': 'patients where the diagnosis is unclear', 'interventionNames': ['Diagnostic Test: endoscopy']}, {'type': 'EXPERIMENTAL', 'label': 'no dysplasia', 'description': 'patients not diagnosed with any cancer', 'interventionNames': ['Diagnostic Test: endoscopy']}], 'interventions': [{'name': 'endoscopy', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['EGD (esophagogastro duodenoscopy)', 'upper GI endoscopy'], 'description': 'Oesophageal endoscopy with biopsy', 'armGroupLabels': ['Adenocarcinoma', "Barrett's oesophagus", 'High-grade dysplasia', 'Indefinite for dysplasia', 'Low-grade dysplasia', 'Other', 'Squamous cell cancer', 'no dysplasia']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'GL1 3NN', 'city': 'Gloucester', 'state': 'Gloucestershire', 'country': 'United Kingdom', 'facility': 'Gloucestershire Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 51.86568, 'lon': -2.2431}}], 'overallOfficials': [{'name': 'Oliver Old, BMedSc MBChB', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gloucestershire Hospitals NHS Foundation Trust'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Exeter', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Bristol', 'class': 'OTHER'}, {'name': 'Gloucestershire Hospitals NHS Foundation Trust', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}