Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2026-02-27 @ 10:05 AM
Study NCT ID:
NCT02730702
Status:
UNKNOWN
Last Update Posted:
2018-08-01
First Post:
2016-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Colon Cancer Risk-stratification Via Optical Analysis of Rectal Ultrastructure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003110', 'term': 'Colonic Neoplasms'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2020-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-07-30', 'studyFirstSubmitDate': '2016-03-28', 'studyFirstSubmitQcDate': '2016-04-01', 'lastUpdatePostDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Whether rectal LEBS readings can predict the presence of advanced adenomas in the colon.', 'timeFrame': 'Through study completion, an average of 1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Colon Cancer']}, 'referencesModule': {'references': [{'pmid': '25991816', 'type': 'BACKGROUND', 'citation': 'Radosevich AJ, Mutyal NN, Eshein A, Nguyen TQ, Gould B, Rogers JD, Goldberg MJ, Bianchi LK, Yen EF, Konda V, Rex DK, Van Dam J, Backman V, Roy HK. Rectal Optical Markers for In Vivo Risk Stratification of Premalignant Colorectal Lesions. Clin Cancer Res. 2015 Oct 1;21(19):4347-4355. doi: 10.1158/1078-0432.CCR-15-0136. Epub 2015 May 19.'}]}, 'descriptionModule': {'briefSummary': 'This is a study whose focus is on understanding the clinical utility of rectal ultrastructure in detecting colonic neoplasm. The method uses Low-coherence Enhanced Backscattering Spectroscopy (LEBS).', 'detailedDescription': 'The investigators use an optic probe which is a small device that uses light to assess the colon tissue. This probe will be used to identify subjects who do and do not have precancerous changes in the colon by capturing the light reflected back from the rectal wall and that will be assessed without the need for colonoscopy and bowel preparation (i.e unprepped). This device may detect early cancerous changes in colon tissue with higher accuracy than current tests.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will be obtained in the gastroenterology clinics.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Subjects are eligible if they were scheduled for colonoscopy for colon cancer screening or surveillance\n\nExclusion Criteria:\n\n* age \\<50\n* personal/family history of colonic neoplasia\n* personal history of coagulopathy\n* (retrospectively) failure to complete or inadequate colonoscopy\n* any patients harboring non-pathoglocially normal rectum (i.e. presence of lesion, inflammation, polyp, adenomas at rectum)'}, 'identificationModule': {'nctId': 'NCT02730702', 'briefTitle': 'Colon Cancer Risk-stratification Via Optical Analysis of Rectal Ultrastructure', 'organization': {'class': 'INDUSTRY', 'fullName': 'American BioOptics, LLC'}, 'officialTitle': 'Colon Cancer Risk-stratification Via Optical Analysis of Rectal Ultrastructure', 'orgStudyIdInfo': {'id': 'ABO 2016-01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'LEBS - Low coherence enhanced backscattering', 'type': 'DEVICE', 'description': 'Unprepped patients will have the LEBS probe brought into contact with the rectal mucosa, upon which 10 random readings will be obtained.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '02118', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'The Quyen Nguyen, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'American BioOptics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': "The investigators will assure the confidentiality of all human subjects' data and will adhere to all HIPAA rules by, for example, de-identifying data as appropriate to ensure compliance with human subject confidentiality requirements. The investigators will share research outcomes through conference presentations, and through publications as soon as is feasible after peer review."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'American BioOptics, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}