Ignite Creation Date:
2025-12-24 @ 9:12 PM
Ignite Modification Date:
2025-12-25 @ 7:01 PM
Study NCT ID:
NCT01192204
Status:
COMPLETED
Last Update Posted:
2015-08-14
First Post:
2010-08-30
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Clinical Evaluation of Bioadhesive Gels for Oral Cancer Chemoprevention
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}, {'id': 'D002278', 'term': 'Carcinoma in Situ'}], 'ancestors': [{'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mallery.1@osu.edu', 'phone': '614 292-5892', 'title': 'Susan R, Mallery DDS, PhD', 'organization': 'The Ohio State University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'While we initially planned to include microvascular densities and COX-2 analyses, there were insufficient tissue samples to collect these data. Therefore as we do not have these data we can not report them.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': '10% FBR Gel', 'description': 'Active 10% FBR containing bioadhesive gel\n\nBioadhesive 10% freeze-dried black raspberry gel: 0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months\n\nNo adverse events', 'otherNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo Gel', 'description': 'Color/consistency matched placebo (no black raspberry) gel\n\nColor/consistency matched placebo gel: 0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months\n\nNo adverse events', 'otherNumAtRisk': 18, 'otherNumAffected': 0, 'seriousNumAtRisk': 18, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Light Microscopic Histologically Scored Diagnoses Pretreatment to Post Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '10% FBR Gel', 'description': 'Active 10% FBR containing bioadhesive gel\n\nBioadhesive 10% freeze-dried black raspberry gel: 0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months'}, {'id': 'OG001', 'title': 'Placebo Gel', 'description': 'Color/consistency matched placebo (no black raspberry) gel\n\nColor/consistency matched placebo gel: 0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months'}], 'classes': [{'title': 'Pretreatment', 'categories': [{'measurements': [{'value': '2.36', 'spread': '0.35', 'groupId': 'OG000'}, {'value': '2.83', 'spread': '0.34', 'groupId': 'OG001'}]}]}, {'title': 'Posttreatment', 'categories': [{'measurements': [{'value': '1.9', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '2.58', 'spread': '0.17', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.048', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Statistical analyses reflect percent change intrapatient pre versus post histologic grade scores', 'groupDescription': 'Wilcoxon matched-pairs signed rank test (intrapatient pre versus post treatment scores)', 'statisticalMethod': 'Wilcoxon matched-pairs signed rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'We used a 2-tailed Mann Whitney U test to evaluate these data.', 'testedNonInferiority': False}, {'pValue': '0.50', 'groupIds': ['OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Statistical analyses reflect percent change pre versus post histologic grade scores', 'groupDescription': 'Wilcoxon matched-pairs signed rank test (pre versus post treatment scores)', 'statisticalMethod': 'Wilcoxon matched-pairs signed rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Before and after the 3 month treatment.', 'description': 'A hemisection of lesional tissue will be conducted before the 3 month treatment to establish a diagnosis and provide a pretreatment baseline for the experimental parameters. Anl excisional biopsy of the treatment site including any remaining residual lesional tissue (excision of oral dysplastic lesions is consistent with current standards of care) will be obtained after 3 months of treatment to provide a posttreatment diagnosis. The 0 to 8 histologic scale was:0=normal with or without hyperkeratosis BEST OUTCOME, 1=atypia, 2=mild dysplasia, 3=mild-moderate dysplasia, 4=moderate dysplasia,5=moderate-severe dysplasia,6=severe dysplasia, 7=carcinoma in situ, 8=invasive oral squamous cell carcinoma (WORST OUTCOME).', 'unitOfMeasure': 'unit on histologic grade scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The population evaluated were as previously described i.e. 22 participants in the BRB gel cohort and 18 participants in the placebo gel cohort.'}, {'type': 'SECONDARY', 'title': 'Changes in Lesional Sizes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '10% FBR Gel', 'description': 'Active 10% FBR containing bioadhesive gel\n\nBioadhesive 10% freeze-dried black raspberry gel: 0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months.'}, {'id': 'OG001', 'title': 'Placebo Gel', 'description': 'Color/consistency matched placebo (no black raspberry) gel\n\nColor/consistency matched placebo gel: 0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months'}], 'classes': [{'categories': [{'measurements': [{'value': '-26.12', 'spread': '5.81', 'groupId': 'OG000'}, {'value': '18.12', 'spread': '4.39', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.002', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Wilcoxon matched-pairs signed rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'specifically, we used the Wilcoxon matched-pairs signed rank test.', 'testedNonInferiority': False}, {'pValue': '0.036', 'groupIds': ['OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Wilcoxon matched-pairs signed rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'pretreatment and posttreatment (3 months treatment duration)', 'description': 'The remaining oral dysplasia lesion will be inspected at each follow up appointment (every 10-14 days). Biopsies will be immediately conducted on patients with any indication of malignant transformation including indurated, rolled borders, nonhealing ulcers, etc. Accordingly, these patients will withdraw from the trial. Participants will also be monitored for any changes consistent with contact mucositis e.g. soreness and erythema at application site. Clinical photographs were taken for the patients records. Pre treatment and post treatment photographs, with a ruler in place, were used for accurate pre and post treatment size measurement. NOTE: if treatment is beneficial, lesional size will decrease which will be reflected as a negative number.', 'unitOfMeasure': 'mm^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Treatment Changes in Loss of Heterozygosity Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '10% FBR Gel', 'description': 'Active 10% FBR containing bioadhesive gel\n\nBioadhesive 10% freeze-dried black raspberry gel: 0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months'}, {'id': 'OG001', 'title': 'Placebo Gel', 'description': 'Color/consistency matched placebo (no black raspberry) gel\n\nColor/consistency matched placebo gel: 0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months'}], 'classes': [{'categories': [{'measurements': [{'value': '0.9', 'spread': '0.02', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '0.03', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': '2-tailed unpaired t test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.16', 'groupIds': ['OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'two-tailed unpaired t test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Before and after the 3 month treatment duration', 'description': 'Laboratory experiments will be conducted to assess the effects of gel treatment on pre and post loss of heterozygosity (LOH) events at loci associated with tumor suppressor genes.', 'unitOfMeasure': 'LOH events', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '10% FBR Gel', 'description': 'Active 10% FBR containing bioadhesive gel\n\nBioadhesive 10% freeze-dried black raspberry gel: 0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months'}, {'id': 'FG001', 'title': 'Placebo Gel', 'description': 'Color/consistency matched placebo (no black raspberry) gel\n\nColor/consistency matched placebo gel: 0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'could not keep recall appointments', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': '41 patients were enrolled in this protocol. 1 patient could not keep the appointments and was referred to his private oral surgeon.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '10% FBR Gel', 'description': 'Active 10% FBR containing bioadhesive gel\n\nBioadhesive 10% freeze-dried black raspberry gel: 0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months'}, {'id': 'BG001', 'title': 'Placebo Gel', 'description': 'Color/consistency matched placebo (no black raspberry) gel\n\nColor/consistency matched placebo gel: 0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The patients were randomly assigned by computer generated numbers to either the BRB or the placebo gel groups.', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.2', 'spread': '1.8', 'groupId': 'BG000'}, {'value': '57.7', 'spread': '2.9', 'groupId': 'BG001'}, {'value': '59.9', 'spread': '2.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-12', 'studyFirstSubmitDate': '2010-08-30', 'resultsFirstSubmitDate': '2015-04-29', 'studyFirstSubmitQcDate': '2010-08-30', 'lastUpdatePostDateStruct': {'date': '2015-08-14', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-08-12', 'studyFirstPostDateStruct': {'date': '2010-08-31', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-08-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Light Microscopic Histologically Scored Diagnoses Pretreatment to Post Treatment', 'timeFrame': 'Before and after the 3 month treatment.', 'description': 'A hemisection of lesional tissue will be conducted before the 3 month treatment to establish a diagnosis and provide a pretreatment baseline for the experimental parameters. Anl excisional biopsy of the treatment site including any remaining residual lesional tissue (excision of oral dysplastic lesions is consistent with current standards of care) will be obtained after 3 months of treatment to provide a posttreatment diagnosis. The 0 to 8 histologic scale was:0=normal with or without hyperkeratosis BEST OUTCOME, 1=atypia, 2=mild dysplasia, 3=mild-moderate dysplasia, 4=moderate dysplasia,5=moderate-severe dysplasia,6=severe dysplasia, 7=carcinoma in situ, 8=invasive oral squamous cell carcinoma (WORST OUTCOME).'}], 'secondaryOutcomes': [{'measure': 'Changes in Lesional Sizes', 'timeFrame': 'pretreatment and posttreatment (3 months treatment duration)', 'description': 'The remaining oral dysplasia lesion will be inspected at each follow up appointment (every 10-14 days). Biopsies will be immediately conducted on patients with any indication of malignant transformation including indurated, rolled borders, nonhealing ulcers, etc. Accordingly, these patients will withdraw from the trial. Participants will also be monitored for any changes consistent with contact mucositis e.g. soreness and erythema at application site. Clinical photographs were taken for the patients records. Pre treatment and post treatment photographs, with a ruler in place, were used for accurate pre and post treatment size measurement. NOTE: if treatment is beneficial, lesional size will decrease which will be reflected as a negative number.'}, {'measure': 'Treatment Changes in Loss of Heterozygosity Events', 'timeFrame': 'Before and after the 3 month treatment duration', 'description': 'Laboratory experiments will be conducted to assess the effects of gel treatment on pre and post loss of heterozygosity (LOH) events at loci associated with tumor suppressor genes.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['FBR, OSCC, chemoprevention'], 'conditions': ['Squamous Cell Carcinoma of Mouth', 'Intraepithelial Neoplasia']}, 'referencesModule': {'references': [{'pmid': '17413405', 'type': 'BACKGROUND', 'citation': 'Menzin J, Lines LM, Manning LN. The economics of squamous cell carcinoma of the head and neck. Curr Opin Otolaryngol Head Neck Surg. 2007 Apr;15(2):68-73. doi: 10.1097/MOO.0b013e328017f669.'}, {'pmid': '15987995', 'type': 'BACKGROUND', 'citation': 'Lefebvre JL. Current clinical outcomes demand new treatment options for SCCHN. Ann Oncol. 2005;16 Suppl 6:vi7-vi12. doi: 10.1093/annonc/mdi452.'}, {'pmid': '10522499', 'type': 'BACKGROUND', 'citation': 'Papadimitrakopoulou VA, Clayman GL, Shin DM, Myers JN, Gillenwater AM, Goepfert H, El-Naggar AK, Lewin JS, Lippman SM, Hong WK. Biochemoprevention for dysplastic lesions of the upper aerodigestive tract. Arch Otolaryngol Head Neck Surg. 1999 Oct;125(10):1083-9. doi: 10.1001/archotol.125.10.1083.'}, {'pmid': '14597742', 'type': 'BACKGROUND', 'citation': 'Rudin CM, Cohen EE, Papadimitrakopoulou VA, Silverman S Jr, Recant W, El-Naggar AK, Stenson K, Lippman SM, Hong WK, Vokes EE. An attenuated adenovirus, ONYX-015, as mouthwash therapy for premalignant oral dysplasia. J Clin Oncol. 2003 Dec 15;21(24):4546-52. doi: 10.1200/JCO.2003.03.544. Epub 2003 Nov 3.'}, {'pmid': '16707609', 'type': 'BACKGROUND', 'citation': 'Lippman SM, Lee JJ, Martin JW, El-Naggar AK, Xu X, Shin DM, Thomas M, Mao L, Fritsche HA Jr, Zhou X, Papadimitrakopoulou V, Khuri FR, Tran H, Clayman GL, Hittelman WN, Hong WK, Lotan R. Fenretinide activity in retinoid-resistant oral leukoplakia. Clin Cancer Res. 2006 May 15;12(10):3109-14. doi: 10.1158/1078-0432.CCR-05-2636.'}, {'pmid': '1574255', 'type': 'BACKGROUND', 'citation': 'Toma S, Benso S, Albanese E, Palumbo R, Cantoni E, Nicolo G, Mangiante P. Treatment of oral leukoplakia with beta-carotene. Oncology. 1992;49(2):77-81. doi: 10.1159/000227016.'}, {'pmid': '8416267', 'type': 'BACKGROUND', 'citation': 'Lippman SM, Batsakis JG, Toth BB, Weber RS, Lee JJ, Martin JW, Hays GL, Goepfert H, Hong WK. Comparison of low-dose isotretinoin with beta carotene to prevent oral carcinogenesis. 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Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1996 Jul;82(1):69-74. doi: 10.1016/s1079-2104(96)80379-9.'}, {'pmid': '18571839', 'type': 'BACKGROUND', 'citation': 'Wang LS, Stoner GD. Anthocyanins and their role in cancer prevention. Cancer Lett. 2008 Oct 8;269(2):281-90. doi: 10.1016/j.canlet.2008.05.020. Epub 2008 Jun 20.'}, {'pmid': '24486592', 'type': 'RESULT', 'citation': 'Mallery SR, Tong M, Shumway BS, Curran AE, Larsen PE, Ness GM, Kennedy KS, Blakey GH, Kushner GM, Vickers AM, Han B, Pei P, Stoner GD. Topical application of a mucoadhesive freeze-dried black raspberry gel induces clinical and histologic regression and reduces loss of heterozygosity events in premalignant oral intraepithelial lesions: results from a multicentered, placebo-controlled clinical trial. Clin Cancer Res. 2014 Apr 1;20(7):1910-24. doi: 10.1158/1078-0432.CCR-13-3159. Epub 2014 Jan 31.'}]}, 'descriptionModule': {'briefSummary': 'This is a multicenter placebo-controlled clinical trial to assess the effects of a topically applied gel on precancerous oral epithelial lesions. A total of 41 participants will be enrolled in this trial, and 22 of them will be enrolled at Ohio State. \\[The remaining 19 participants will be enrolled at the University of North Carolina (9 participants) and the University of Louisville (8 participants)\\]. At all three institutions, half of the participants will randomly be assigned to the 10% FBR gel (0.5 gm four times daily for 3 months), while half will enter the placebo control arm. All trial participants will have a pretreatment (including lesional and perilesional tissue) biopsy taken before and an excisional biopsy after 3 months of treatment. As pretreatment indices are compared to post treatment effects on each patient, patients serve as their own internal control. Pretreatment lesional biopsies are obtained to establish a pretreatment diagnosis and provide a pretreatment baseline for the experimental parameters.', 'detailedDescription': 'Forty one (41) patients with microscopically confirmed premalignant oral epithelial disease (epithelial dysplasia) will be enrolled in this trial at three clinical centers, i.e. the Ohio State University, University of North Carolina at Chapel Hill and University of Louisville. At all three institutions, half of the participants will randomly be assigned to the 10% FBR gel (0.5 gm four times daily for 3 months), while half will enter the placebo control arm.\n\nIn accordance with the established standard of care, all participants need to have biopsies taken of their suspicious oral lesions to establish the diagnosis (non research). Trial participants will have three total biopsies. Pretreatment biopsies will entail: 1) perilesional tissue and single saliva sample for FBR metabolic profiling studies (tissue and saliva will be obtained 15 minutes after a single 0.5 gm application of 10% FBR gel for metabolic profiling. Gel application and nonlesional biopsy will be obtained before incisional biopsy of lesional tissue), and 2) a hemisection of lesional tissue to establish a diagnosis and provide a pretreatment baseline for the experimental parameters. While the pretreatment biopsy includes removal of both perilesional and lesional tissue, there will only be one surgical wound as the perilesional tissue is contiguous with the lesional tissue. A final excisional biopsy of the treatment site including any remaining residual lesional tissue (excision of oral dysplastic lesions is consistent with current standards of care) will be obtained after 3 months of treatment. The experimental design permits each patient to serve as their own internal control. Briefly, these following parameters will be monitored in all participants (comparisons made relative to patient-matched pretreatment to posttreatment biopsies): 1) light microscopic diagnoses, 2) clinical appearances and lesional sizes, 3) microarray gene expression analyses, 4) microvascular densities of superficial connective tissues, 5) LOH indices at loci associated with tumor suppressor genes, 6) intraepithelial levels of COX-2 and iNOS protein (image analysis quantified immunohistochemistry), 7) comparison of FBR metabolic profiles relative to extent of chemopreventive efficacy noted.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Ages: 21 to 80\n2. Microscopically confirmed premalignant oral epithelial disease\n3. No previous history of cancer (with the exception of basal cell carcinoma of the skin)\n4. Tobacco free for at least six weeks prior to entrance in the trial and remain tobacco-free for the three month duration of the study\n5. Availability for necessary study follow-up evaluations (every 10 to 14 days during the trial)\n6. Capable of providing informed consent.\n\nExclusion Criteria:\n\n1. Previous history of cancer (with the exception of basal cell carcinoma of the skin)\n2. Current use of tobacco products or refusal to remain tobacco-free for the three month duration of the study\n3. Lack of microscopically confirmed premalignant oral epithelial changes\n4. Microscopic diagnosis of oral squamous cell carcinoma\n5. Previous history of radiation therapy on same side of the head and neck region\n6. History of allergy to any kind of berry\n7. Women who are determined to be pregnant or plan to be pregnant during the trial\n8. Women who are nursing.'}, 'identificationModule': {'nctId': 'NCT01192204', 'briefTitle': 'Clinical Evaluation of Bioadhesive Gels for Oral Cancer Chemoprevention', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University'}, 'officialTitle': 'Clinical Evaluation of Bioadhesive Gels for Oral Cancer Chemoprevention', 'orgStudyIdInfo': {'id': '2009C0086'}, 'secondaryIdInfos': [{'id': 'RC2CA148099', 'link': 'https://reporter.nih.gov/quickSearch/RC2CA148099', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '10% FBR containing bioadhesive gel', 'description': 'Drug consisting of 10% FBR containing bioadhesive gel. Participants instructed to apply 0.5 gm of 10% FBR containing bioadhesive gel four times a day to lesional site', 'interventionNames': ['Drug: 10% FBR containing bioadhesive gel']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Gel', 'description': 'Color/consistency matched placebo (no black raspberry) gel', 'interventionNames': ['Drug: placebo gel']}], 'interventions': [{'name': '10% FBR containing bioadhesive gel', 'type': 'DRUG', 'otherNames': ['BRB gel'], 'description': '0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months', 'armGroupLabels': ['10% FBR containing bioadhesive gel']}, {'name': 'placebo gel', 'type': 'DRUG', 'otherNames': ['BRB devoid placebo gel'], 'description': '0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months', 'armGroupLabels': ['Placebo Gel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Louisville, School of Dentistry', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina at Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '43202', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State University, College of Dentistry', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'Susan R Mallery, DDS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ohio State University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ohio State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Louisville', 'class': 'OTHER'}, {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Susan Mallery DDS, PhD', 'investigatorAffiliation': 'Ohio State University'}}}}