2024
Randomized Phase II Trial of Imiquimod with or without 9-Valent HPV Vaccine versus Observation in Patients with High-grade Pre-neoplastic Cervical Lesions (NCT02864147)
Sheth S, Oh J, Bellone S, Siegel E, Greenman M, Mutlu L, McNamara B, Pathy S, Clark M, Azodi M, Altwerger G, Andikyan V, Huang G, Ratner E, Kim D, Iwasaki A, Levi A, Buza N, Hui P, Flaherty S, Schwartz P, Santin A. Randomized Phase II Trial of Imiquimod with or without 9-Valent HPV Vaccine versus Observation in Patients with High-grade Pre-neoplastic Cervical Lesions (NCT02864147). Clinical Cancer Research 2024, 30: of1-of10. PMID: 38592381, DOI: 10.1158/1078-0432.ccr-23-3639.Peer-Reviewed Original ResearchConceptsRandomized phase II trialCD4/CD8 T cellsT cellsHPV clearanceArm BNo significant differenceClinical surveillanceRate of HPV clearanceSecondary outcomesPre-neoplastic cervical lesionsCervical intraepithelial neoplasiaT cell infiltrationT cell responsesSignificant differenceCIN3 patientsIntraepithelial neoplasiaArm ACervical lesionsImiquimod groupSurveillance armVaginal suppositoriesProspective trialsArm CHPV vaccinationImiquimod
2021
High-Risk Human Papillomavirus Testing, Genotyping, and Histopathologic Follow-up in Women With Abnormal Glandular Cells on Papanicolaou Tests
Zuo T, Levi AW, Lin Q, Abi-Raad R, Adeniran AJ, Cai G. High-Risk Human Papillomavirus Testing, Genotyping, and Histopathologic Follow-up in Women With Abnormal Glandular Cells on Papanicolaou Tests. American Journal Of Clinical Pathology 2021, 156: 569-576. PMID: 33728437, DOI: 10.1093/ajcp/aqaa265.Peer-Reviewed Original ResearchConceptsPositive hrHPV resultsCervical intraepithelial neoplasiaHrHPV resultsHrHPV testingCIN2-3Intraepithelial neoplasiaPapanicolaou testCervical carcinomaHigh risk human papillomavirus statusHigh-risk human papillomavirus (hrHPV) testingHigh-grade cervical intraepithelial neoplasiaLow-grade cervical intraepithelial neoplasiaHuman papillomavirus testingHuman papillomavirus (HPV) statusManagement of patientsAbnormal glandular cellsHPV genotypesHPV subtypesAGC casesPap testFollow-upHistologic followHigh lesionsType 16Reactive changes
2014
Methylation of Twelve CpGs in Human Papillomavirus Type 16 (HPV16) as an Informative Biomarker for the Triage of Women Positive for HPV16 Infection
Brandsma JL, Harigopal M, Kiviat NB, Sun Y, Deng Y, Zelterman D, Lizardi PM, Shabanova VS, Levi A, Yaping T, Hu X, Feng Q. Methylation of Twelve CpGs in Human Papillomavirus Type 16 (HPV16) as an Informative Biomarker for the Triage of Women Positive for HPV16 Infection. Cancer Prevention Research 2014, 7: 526-533. PMID: 24556390, DOI: 10.1158/1940-6207.capr-13-0354.Peer-Reviewed Original ResearchConceptsCervical intraepithelial neoplasiaCytology samplesCutoff scoreColposcopy of womenCervical cancer preventionManagement of womenDetection of CIN3Cervical cytology samplesHuman papillomavirus type 16Human papillomavirus type 16 DNAMethylation biomarkersPapillomavirus type 16Histologic severityIntraepithelial neoplasiaCervical cancerHPV16 infectionCancer preventionDNA bisulfite sequencingType 16Prognostic potentialAccurate biomarkersProspective biomarkersScreening testInformative biomarkersBiomarkersPrior High-Risk Human Papillomavirus Testing and Papanicolaou Test Results of 70 Invasive Cervical Carcinomas Diagnosed in 2012: Results of a Retrospective Multicenter Study
Zhao C, Li Z, Nayar R, Levi AW, Winkler BA, Moriarty AT, Barkan GA, Rao J, Miller F, Fan F, Zhou Z, Si Q, Fischer AH, Sturgis CD, Jing X, Marshall CB, Witt BL, Birdsong GG, Crothers BA. Prior High-Risk Human Papillomavirus Testing and Papanicolaou Test Results of 70 Invasive Cervical Carcinomas Diagnosed in 2012: Results of a Retrospective Multicenter Study. Archives Of Pathology & Laboratory Medicine 2014, 139: 184-8. PMID: 24694342, DOI: 10.5858/arpa.2014-0028-oa.Peer-Reviewed Original ResearchConceptsInvasive cervical cancerInvasive cervical carcinomaHrHPV testingCervical cancerCervical carcinomaHPV testingHistologic diagnosisPersistent high-risk human papillomavirus (HPV) infectionHigh-risk human papillomavirus (hrHPV) testingHigh-risk human papillomavirus infectionHigh-risk HPV testingPrimary HPV testingHuman papillomavirus testingHuman papillomavirus infectionRetrospective multicenter studyCervical epithelial lesionsCurrent screening guidelinesSquamous cell carcinomaHPV ratesPapillomavirus infectionMulticenter studyScreening guidelinesCell carcinomaPapanicolaou testSingle institution
2012
Increasing Cytotechnologist Workload Above 100 Slides per Day Using the BD FocalPoint GS Imaging System Negatively Affects Screening Performance
Levi AW, Galullo P, Gordy K, Mikolaiski N, Schofield K, Elsheikh TM, Harigopal M, Chhieng DC. Increasing Cytotechnologist Workload Above 100 Slides per Day Using the BD FocalPoint GS Imaging System Negatively Affects Screening Performance. American Journal Of Clinical Pathology 2012, 138: 811-815. PMID: 23161714, DOI: 10.1309/ajcptydd9g2ncumf.Peer-Reviewed Original ResearchMeSH KeywordsCarcinoma, Squamous CellCytodiagnosisDiagnostic ImagingFalse Negative ReactionsFemaleHumansImage Processing, Computer-AssistedMass ScreeningMedical Laboratory PersonnelQuality ControlSensitivity and SpecificityTime FactorsUterine Cervical DysplasiaUterine Cervical NeoplasmsVaginal SmearsWorkloadThe Positive Impact of Simultaneous Implementation of the BD FocalPoint GS Imaging System and Lean Principles on the Operation of Gynecologic Cytology
Wong R, Levi AW, Harigopal M, Schofield K, Chhieng DC. The Positive Impact of Simultaneous Implementation of the BD FocalPoint GS Imaging System and Lean Principles on the Operation of Gynecologic Cytology. Archives Of Pathology & Laboratory Medicine 2012, 136: 183-9. PMID: 22288966, DOI: 10.5858/arpa.2011-0139-oa.Peer-Reviewed Original Research
2011
Implementation of FocalPoint GS location‐guided imaging system
Levi AW, Chhieng DC, Schofield K, Kowalski D, Harigopal M. Implementation of FocalPoint GS location‐guided imaging system. Cancer Cytopathology 2011, 120: 126-133. PMID: 22505211, DOI: 10.1002/cncy.20187.Peer-Reviewed Original ResearchConceptsASC-US casesHR-HPV positive rateLow-risk patient populationHigh-risk human papillomavirusASC-US interpretationsRoutine clinical settingPromising screening toolPap testHuman papillomavirusPapanicolaou testPatient populationBacterial vaginosisDrug AdministrationSIL ratioClinical settingScreening toolDiagnostic categoriesLaboratory information systemGynecologic cytologyPrimary screeningSignificant increaseFalse negative fractionPositive rateHigh percentageCurrent studyUse of high‐risk human papillomavirus testing in patients with low‐grade squamous intraepithelial lesions
Levi AW, Harigopal M, Hui P, Schofield K, Chhieng DC. Use of high‐risk human papillomavirus testing in patients with low‐grade squamous intraepithelial lesions. Cancer Cytopathology 2011, 119: 228-234. PMID: 21732551, DOI: 10.1002/cncy.20172.Peer-Reviewed Original ResearchConceptsLow-grade squamous intraepithelial lesionsHR-HPV testingHPV testingCIN 2Colposcopy rateHR-HPVRelative light units/cutoffCervical intraepithelial neoplasia 2High-risk human papillomavirusHR-HPV statusRLU/COIntraepithelial neoplasia 2Hybrid Capture 2Squamous intraepithelial lesionsCIN 1 lesionsLarge teaching hospitalNegative predictive valueLSIL cytologyHPV statusIntraepithelial lesionsCapture 2Human papillomavirusTeaching hospitalCytologic diagnosisSevere lesions
2003
Atypical squamous cells of undetermined significance in liquid‐based cytologic specimens
Levi AW, Kelly DP, Rosenthal DL, Ronnett BM. Atypical squamous cells of undetermined significance in liquid‐based cytologic specimens. Cancer 2003, 99: 191-197. PMID: 12925979, DOI: 10.1002/cncr.11507.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAdultAgedAged, 80 and overColposcopyCost-Benefit AnalysisDNA, ViralFemaleFollow-Up StudiesHumansMiddle AgedModels, StatisticalPapanicolaou TestPapillomaviridaePapillomavirus InfectionsPatient Care PlanningPolymerase Chain ReactionPractice Guidelines as TopicSensitivity and SpecificityTumor Virus InfectionsUterine Cervical DysplasiaUterine Cervical NeoplasmsVaginal SmearsConceptsLow-grade squamous intraepithelial lesionsSquamous intraepithelial lesionsHigh-grade squamous intraepithelial lesionsAtypical squamous cellsHPV test resultsHigh-grade lesionsASCUS smearsHPV-positive smearsIntraepithelial lesionsSquamous cellsUndetermined significanceHuman papillomavirus (HPV) DNA testingASCUS interpretationHigh-risk HPV typesHPV-positive casesHPV DNA testingHigh-risk typesLiquid-based Pap smearsLow-grade lesionsDNA testingColposcopy triageHPV testingASCUS cytologyHPV typesPap smear