Immunohistochemical Staining of p16 for the Screening of Cervical Cancer

checkorphan
Learn more about:
Cervical intraepithelial neoplasia
Related Access Program
MacroGenics – HER2-positive Carcinoma Andrei Iagaru – Carcinoid Tumors Jonsson Comprehensive Cancer Center – Carcinoid Cancer Jonsson Comprehensive Cancer Center – Urothelial Carcinoma Ureteral Location Advanced Accelerator Applications – Midgut Carcinoid Tumor Ariad Pharmaceuticals – Carcinoma Pfizer – Carcinoma, Non-Small-Cell Lung
Related Clinical Trial
Role of Liquid Biopsies in HPV-associated Cancer Treatment Monitoring Educational Video’s Impact on Knowledge Regarding Cervical Cancer Screening Primary Cervical Cancer Screening by Self-sampling HPV Test Vaginal Microbiome and HPV Pre-malignant and Cervical Dysplasia The Role of FAM19A4 and Hsa-mir-124 Methylation in Predicting Prognosis of Untreated Cervical Intraepithelial Neoplasia 2 (CIN 2) Circulating Human Papilloma Virus (HPV) DNA for the Screening and Surveillance of Gynecologic Cancers Retrospective Study on the Evolution of CIN 1 to 3 in Per and Postpartum in Nancy From 2014 to 2022 Clinical, Translational and Biomarker-Based Female Genital HPV Induced Dysplasia and Cancer Screening Study Using Cf-HPV-DNA Blood Tests Diagnostic Cervical Conization for Persistent Infection or Integration of HPV DEFLAGYN® Vaginal Gel and Spontaneous Remission and Regression of Unclear Cervical Smears and HPV High-risk Infections A Study of ABI-2280 Vaginal Tablet in Participants With Cervical Intraepithelial Neoplasia A Study on the Immune Response and Safety of an Adjuvanted Human Papillomavirus Vaccine When Given to Healthy Women 16 to 26 Years of Age Predicting Response In Cervical Intraepithelial Neoplasia to Topical Imiquimod Treatment Cervical Cancer Screening Strategies DNA PAX1 and JAM3 Methylation for Cervical Cancer Screening The Organ Transplant Recipient HPV and Skin Cancer Study Effect of HPV Integration on Prognosis of Young Women With CIN2 in China Immunogenicity of Gardasil-9 HPV Vaccine in People Living With HIV Prevention and Screening Towards Elimination of Cervical Cancer HPV-based Screening Among Women 23-29 Years of Age Clinical Evaluation of Detection of High Risk HPV in Urine The Vaginal Microecology and Innate Immunity After Focused Ultrasound Ablation Treatment for CIN Large Loop Excision of the Transformation Zone (LLETZ) With vs Without IntraOperative Application of Lugol’s Iodine Evaluation of New Diagnostic Tool Using Fluorescence to Detect High-grade Vulvar Intraepithelial Neoplasia Optimization of Screening Algorithms for Cervical and Anal High-Grade Squamous Intraepithelial Lesions in People With HIV in Mexico and Puerto Rico Low-cost Imaging Technology for Global Prevention of Cervical Cancer Biomarkers Predictive for Cervical Intraepithelial Neoplasia Grade 2 (CIN2) Evolvement The Durability of Protection and Immuno-persistence Study of a Recombinant HPV 16/18 Bivalent Vaccine in Female The Durability of Protection Study of a Recombinant HPV 16/18 Bivalent Vaccine in Female The Use of the LuViva Advanced Cervical Scan to Identify Women at High-Risk for Cervical Neoplasia Depth of Necrosis in Normal Cervical Epithelium After 85% Trichloroacetic Acid (TCA) Application Extended VALidation of HUman Papillomavirus Assays and Collection DEvices for HPV Testing on Self-samples Conservative Management of HSIL in Patients With Future Pregnancy Aspiration Clinical Validation of Cervical Cancer Screening Methods Comparison of LLETZ Versus LEEP for the Treatment of Cervical Dysplasia Effectiveness of Cervical Screening in Unvaccinated, Herd Effect Protected Women (HPV400) Virtual Reality: Influence on Satisfaction, Pain, and Anxiety in Patients Undergoing Colposcopy Treatment of Cervical Intraepithelial Neoplasia (CIN) Grade III With Non-invasive Physical Plasma Immuno-persistence Study of a Recombinant Human Papillomavirus 16/18 Bivalent Vaccine in Preadolescent Girls (54m) Pembrolizumab for the Treatment of High-Grade Vulvar, Vaginal, or Cervical Intraepithelial Neoplasia Self-Testing Options in the Era of Primary HPV Screening for Cervical Cancer Trial DNA Methylation Testing for the Screening of Uterine Cervical Lesion Immunohistochemical Staining of p16 for the Screening of Cervical Cancer CASUS: Validation for Detection of Precursor Lesions CASUS: Improved and Quality Assured Collection of First-void Urine Efficacy and Safety of Cevira® in Patients With Cervical Histologic High-grade Squamous Intraepithelial Lesions (HSIL) Lugol’s Solution in Addition to Acetic Acid During Colposcopy A Phase I Study of E7 TCR T Cell Immunotherapy for High-Grade Cervical Intraepithelial Neoplasia Imiquimod, Fluorouracil, or Observation in Treating HIV-Positive Patients With High-Grade Anal Squamous Skin Lesions Primary Imiquimod Treatment Versus Surgery for Vulvar Intraepithelial Neoplasia Safety and Effectiveness of Giving Isotretinoin to HIV-Infected Women to Treat Cervical Tumors Costa Rican Natural History Study of HPV and Cervical Neoplasia Measurement of Digital Colposcopy for Fluorescence Spectroscopy of TNC Using a Second Device Effect of Salpingectomy During Conservative Hysterectomy Feasibility of Delphi Screener for Cervical Cytology Study of Topical ABI-1968 in Subjects With Precancerous Cervical Lesions From Human Papillomavirus (HPV) Infection. Study of Topical ABI-1968 in Subjects With Precancerous Cervical Lesions From Human Papillomavirus (HPV) Infection Gene Therapy Follow up for Subjects Previously Enrolled in NCI Experimental Transplantation and Immunology Branch Studies Home-Based or Clinic-Based Human Papillomavirus (HPV) Screening Viral Load Determination and Biomarkers of High Risk Human Papillomavirus (HPV) – Types in HIV-positive Men Immuno-persistence Study of a Recombinant Human Papillomavirus 16/18 Bivalent Vaccine in Preadolescent Girls A Bridging Study of a Recombinant Human Papillomavirus 16/18 Bivalent Vaccine in Preadolescent Girls TWO DİFFERENT ELECTROSURGERY DEVICES AS MONOPOLAR HOOC AND PLASMAKINETIC BIPOLAR SPATULA EFFECTIVENESS DURING COLPOTOMY Minimally Invasive Benign Hysterectomy HRME in the Screening of Cervical Cancer Precursor Lesions in Brazil (UH3 – Brazil) Diagnostic Imaging Aid for Management of Cervical Lesions Cervical Cancer Early Endpoints and Determinants Triage Strategies in Cervical Cancer Prevention Genotypification and Predisposing Factors in Human Papilloma Virus Infection Development of Immunological Assays for the Evaluation of Tumor Antigen Specific Immunity Chinese Cancer Prevention Study(CHICAPS) The Development of a “Mother/Child, Screen, Treat and Vaccinate Program” in Manchay and Iquitos, Peru HRME: Screening for Cervical Cancer and Its Precursors in Low‐Resource Settings A Trial for Patients With Advanced/Recurrent Cervical Cancer HPV Genotyping by DR. HPV Genotyping in Vitro Diagnostic Device (IVD) Kit in Exfoliated Cells of the Uterine Cervix Human Papillomavirus (HPV) and Risk of Cervical Precancer and Cancer Self-sampling for Non-attenders to Cervical Cancer Screening HPVPro Study: Comparison of HPV Detection in Clinician-collected Cervical Swabs and Self-sampled Cervicovaginal Swabs Acceptability and Efficacy of Self-sampling for Cervical Cancer Screening: A Pilot Study Clinical Trial for the Use of a Novel Cell Collector Device to Retrieve Cells From the Uterine Cervix Human Papillomavirus Epidemiology in Nigeria Impact of HPV Vaccine On The Prevalence Of HPV In Norway Deciphering Mechanisms Underlying Cancer Immunogenicity Expression of Oncogenic Human Papillomavirus E6/E7 Protein in Tampon Self-Tests Spectroscopic Evaluation of Cervical Neoplasia Evaluating the 2-dose Immunization Schedule of Human Papillomavirus (HPV)-16/18 in Adolescent Females Immune Response to the Human Papillomavirus Vaccine in Young Women With Inflammatory Bowel Disease Safety and Efficacy Study of Antiviral Local Application to Treat High Grade Cervical Intraepithelial Lesions (CIN2/3) Human Papilloma Virus (HPV) Vaccine Trial in Young Adolescent Women With GlaxoSmithKline Biologicals’ (GSK Bio) HPV-16/18 Vaccine Participation in Screening for Cervical Cancer: Interest of a Self-sampling Device Provided by the General Practitioner Self-sampling and Human Papillomavirus (HPV)-Testing for Unscreened Women in Cervical Cancer Prevention Human Papillomavirus (HPV) Vaccine Consistency and Non-inferiority Trial in Young Adult Women DNA Methylation Biomarkers for Cervical Cancer Screening Evaluation of in Vitro Devices on Self-collected Vaginal Swab and Urine Sample for Testing of Human Papilloma Virus The SAFE Study: Satisfaction and Adherence to Follow-Up With Colposcopy Exams Impact of AV2 Antiviral Drug on the Treatment of HPV-associated Lesions of the Uterine Cervix Can Text Reminders Improve Uptake of Cervical Screening? Comparing Two Techniques of Haemostasis After Cervical Conization A Comparison Study of Two Community Outreach-Based Approaches to Increase Participation of Women Living in the Mississippi Delta in Cervical Cancer Screening FASTER-Tlalpan Study HPV Integration Testing for Human Papillomavirus-Positive Women Randomized Implementation of Primary HPV Testing in the Organized Screening for Cervical Cancer in Stockholm Dose-Ranging Study of Recombinant Human Papillomavirus Virus 16/18 Bivalent Vaccine Cervical Cytology – Do SMS Reminders Increase Participation in the Cervical Screening Programme? Comparison of Pelvic Lymphadenectomy Versus Isolated Sentinel Lymph Node Biopsy Procedure for Early Stages of Cervical Cancers : a Multicenter Study With Evaluation of Medico-economic Impacts The Study of Folate Receptor-Mediated Staining Solution (FRD™) In Cervical Lesion Detection Effectiveness of Cervical Screening in HPV Vaccinated Women Randomized Controlled Trial to Study Interventions to Increase Participation in Cervical Cancer Screening Program Human Papillomavirus (HPV) Testing to Improve Cervical Cancer Screening in the Mississippi Delta Validation of Human Papillomavirus Assays and Collection Devices for Self-samples and Urine Samples Effect of Fee on Attendance in Cervical Cancer Screening Cervix Cytological Screening – Comparison of Tampon Self-Test and the Routine Smear. Study of the Diagnostic Efficacy of “Real Time” Niris 1300e Optical Coherence Tomography (OCT) Imaging System in the Management of Pre-invasive and Invasive Neoplasia of the Uterine Cervix LLETZ Under General Versus Local Anesthesia Buffered Lidocaine for Loop Electrosurgical Excision Procedures (LEEPs) Trial on Safety and Pharmacokinetics of Intravaginal Curcumin IMproved PRactice Outcomes and Value Excellence in Colposcopy Visual Inspection With Acetic Acid Compared to Lugol’s Iodine in HIV-infected Women Phase I, Open-Label Study of the Safety, Tolerability, and Immunogenicity PEK Fusion Protein Vaccine Clinical Evaluation of Polarized Light Assisted Colposcopy Indirect Comparison Topotecan Cervical Carcinoma Meta-analysis of Efficacy of Topotecan Efficacy Study of Diathermy Cone Biopsy for the Treatment of Cervical Intraepithelial Lesion Quality of Life in Thai Women Diagnosed Cervical Cancer at King Chulalongkorn Memorial Hospital Serum IGF-II and Cancer: Can IGF II Levels be Used to Monitor and Screen Patients Specifically for Cervical Cancer A Follow-up Extension Study to Evaluate the Persistence of Immune Response to GSK Biologicals’ HPV Vaccine in Healthy Chinese Female Subjects Who Received Three Doses of the Vaccine in the HPV-058 Study TMTP1-ICG Mapping in Colposcopy-directed Biopsy Hemodynamic Stability of Bupivacaine With and Without Adrenaline for Paracervical Block for Cervical Conization Immediate Treatment vs Colposcopic Follow-up for Biopsy-Proven CIN 1 Diagnosis of Cervical Lesions in Women With Unhealthy Looking Cervix Construct Validity of a Large Loop Excision of the Transformation Zone (LLETZ) Training Model Endocervical Evaluation With the Curette Versus Cytobrush for the Diagnosis of Dysplasia of the Uterine Cervix Randomized Controlled Trial of Human Papillomavirus Testing in Primary Cervical Cancer Screening Safety and Efficacy of GX-188E DNA Therapeutic Vaccine Administered by Electroporation After Observation The HPV Self-test as a Test of Cure in Madagascar REVEAL 2 Trial (Evaluation of VGX-3100 and Electroporation for the Treatment of Cervical HSIL) A Trial of Two Electrosurgical Conizations: Histopathological Analysis of Excision Margins Cold Knife Conization With and Without Lateral Hemostatic Sutures DC Vaccines Targeting HPV16/18 E6/E7 Protein to Regress CINI/CIN2 A Phase III Study of Human Papillomavirus (HPV)-16/18 Vaccine. Evaluation of Human Papilloma Virus (HPV) Self-testing to Increase Screening Uptake Improving Cervical Cancer Screening Among HIV-Infected Women in India REVEAL 1 (Evaluation of VGX-3100 and Electroporation for the Treatment of Cervical HSIL) Compass – Randomised Controlled Trial of Primary HPV Testing for Cervical Screening in Australia chemQbiosciences:Manual Liquid Based Cytology A Dose-finding Study of MAL and HAL Photodynamic Therapy of Cervical Premalignant Lesions. Diagnostic and Prognostic Value of p16INK4a Expression in Low Grade Squamous Intraepithelial Lesions of the Cervix. Music Listening to Reduce Pain and Anxiety During LEEP A Comparison of Immediate Treatment of CIN1 With Cryotherapy and 12 Month Cytology Follow up in HIV Seropositive Women Aminolaevulinic Acid Photodynamic Therapy of Cervical Persistent HPV Infection and Cervical Neoplasia HPV DNA Vaccine Via Electroporation for HPV16 Positive Cervical Neoplasia The Correlations Between HPV L1-Specific Immunologic Responses in Cervical Cancer and Cervical Intraepithelial Neoplasia (CIN) Patients and Their Prognosis Safety and Tolerability of Cidofovir Gel Applied on Cervix Squamous Lesions Lidocaine Spray Compared With Submucosal Injection During LEEP: a Randomized Controlled Trial A Post Marketing Surveillance (PMS) Study to Monitor the Safety of GlaxoSmithKline (GSK) Biologicals’ Human Papillomavirus (HPV) Vaccine in Female Chinese Subjects Comparison of Human Papillomavirus Integrated DNA and Messenger RNA in Cervical Neoplasia Cervical And Self-Sample In Screening Study Randomized Trial of Vaginal Self Sampling for Human Papillomavirus (HPV) Factors Associated With Residual Disease In The Central Cone Trial to Evaluate Single- and Double- Freeze Cryotherapy in the Prevention of Cervical Neoplasia Colposcopy Versus HPV Testing to Identify Persistent Cervical Precancers Optimal Strategy for the Management of ASCUS Cytology in Health Care Services of Medellin, Colombia V501 Safety and Efficacy Study in Japanese Women Aged 16 to 26 Years (V501-110) Effectiveness of HPV Vaccine in Thai Adult Women Topical Fluorouracil and Imiquimod in Treating Patients With High-Grade Cervical Intraepithelial Neoplasia Dose-finding Study of Hexaminolevulinate (HAL) Photodynamic Therapy (PDT) to Treat Cervical Neoplasia Artesunate Vaginal Inserts for the Treatment of CIN2/3 A Two-Stage Phase 2 Study Of A-007 Topical Gel in High-Grade Squamous Intraepithelial Lesions (HSIL) Trial23 – A Method Study on Cervical Screening in Women Offered HPV-vaccination as Girls An Innovative Treatment for Cervical Pre Cancer A Study of Amolimogene (ZYC101a) in Patients With High Grade Cervical Intraepithelial Lesions of the Uterine Cervix LLETZ Under Direct Colposcopic Vision The Efficacy of Tachosil® for Prevention of Hemorrhage After Loop Electrosurgical Excisional Procedure (LEEP) Safety and Efficacy of GX-188E DNA Therapeutic Vaccine Administered by Electroporation After Observation LLETZ With Videocolposcopy Versus LLETZ With Binocular Colposcopy Imiquimod Treatment of Residual or Recurrent CIN Lesions: a Study Protocol Colposcopy and Dynamic Spectral Imaging (DSI) Imiquimod Treatment of High-grade CIN Treatment of High-Grade Pre-Neoplastic Cervical Lesions (CIN 2/3) Safety and Efficacy of GX-188E Administered Via EP Plus GX-I7 or Imiquimod. Topical Imiquimod vs. LEEP for Women With Carcinoma In-situ of the Cervix Feasibility of the Management of Severe Cervical Dysplasia in a Single Visit Video Colposcopy in Women With Dysplasia Randomized Clinical Trial on Clinical Management of ASCUS and LSIL (ALTS) Imiquimod Treatment of CIN Lesions HPV Integration Testing for Cervical Cancer Screening Hemostatic Procedure After Biopsy of the Cervix HPV-cytology Testing Versus Cytology Testing for the Detection of High Grade CIN An Exploratory Safety and Immunogenicity Study of HPV16+ Immunotherapy VB10.16 in Women With HSIL; CIN 2/3) Safety and Efficacy of A-007 Topical Gel in the Treatment of High-Grade Squamous Intraepithelial Lesions (HSIL) of the Cervix Prevaccination Study of Cervical Human Papillomavirus Types in Yangtze River Delta Area, China Green Tea Extract in Preventing Cervical Cancer in Patients With Human Papillomavirus and Low-Grade Cervical Intraepithelial Neoplasia An Assessment of an Attenuated Live Listeria Vaccine in CIN 2+ Phase 2 Clinical Trial to Evaluate the Safety and Efficacy of Plasmid DNA Therapeutic Vaccine(GX-188E) Multispectral Digital Colposcope With Probe for Detection of Cervical Intraepithelial Neoplasia A Study of VGX-3100 DNA Vaccine With Electroporation in Patients With Cervical Intraepithelial Neoplasia Grade 2/3 or 3 Fischer Cone Biopsy Excisor Versus Loop Excision Procedure for Conization A Phase III Randomized Trial of Topical Vaginal Fluorouracil (5-Fluorouracil, 5-FU) Maintenance Therapy Versus Observation After Standard Treatment for High-Grade Cervical Dysplasia in HIV-Infected Women Therapeutic Vaccination for Patients With HPV16+ Cervical Intraepithelial Neoplasia (CIN2/3) Coherence Imaging of the Cervical Epithelium With Scanning a/LCI Vaccine Therapy in Preventing Cervical Cancer in Patients With Cervical Intraepithelial Neoplasia See and Treat in an Outpatient Setting in Women Above 45 Years With Cervical Dysplasia Factors Predicting Persistence of Oncogenic HPV and Cervical Dysplasia in HIV Infected Kenyan Women Smoking Cessation in Women With Gynecological Conditions Recurrence in High-grade Lesions After Conization Evaluation of Initial High Risk Human Papillomavirus (HR-HPV) Viral Load as Predictive Marker for Cervical Intraepithelial Neoplasia Grade 1 (CIN1) Persistence Management of Cervical Intraepithelial Neoplasia Grade 2 Photodynamic Therapy Using Lutetium Texaphyrin in Treating Patients With Cervical Intraepithelial Neoplasia Celecoxib in Treating Patients With Cervical Intraepithelial Neoplasia Aminolaevulinic Acid Photodynamic Therapy for HPV+ Low Grade Cervical Intraepithelial Neoplasia (LSIL;CIN1) An Innovative Treatment for Cervical Precancer (UH3) Evaluating Materials to Educate Patients About Cervical Dysplasia A Efficacy and Safety Study of Composite Gel Containing Black Raspberry Extract in Removing HPV From Patients With Cervical Intraepithelial Neoplasia(CIN) After Cervical Conization Performance, Safety, and Efficacy of a New Cyrotherapy Device for Cervical Dysplasia Performance, Safety, and Efficacy of a New Cryotherapy Device for Cervical Dysplasia [Part II] Music and Colposcopy in Women With Cervical Dysplasia. Use of Human Papillomavirus Persistence for Determination of Treatment Efficacy Among Women With Cervical Dysplasia ITIC (Imiquimod Therapy in Cervical Intraepithelial Neoplasia)-Trial A Study of RO5217790 in Participants With High Grade Cervical Intraepithelial Neoplasia (CIN) Associated With High Risk Human Papillomavirus (HR-HPV) Infection Local Hyperthermia for the Treatment of Cervical Intraepithelial Neoplasias Comparison of Cervical CIN II/III Treatment Outcomes With Thermal Ablation Device A Trial to Evaluate the Efficacy and Safety of BLS-ILB-E710c in Patients With Cervical Intraepithelial Neoplasia 2/3 (CIN2/3) A Pilot Study of EM-1421 for the Treatment of Cervical Intraepithelial Neoplasia Topical Imiquimod Versus Conization to Treat Cervical Intraepithelial Neoplasia Dose-finding, Safety Study of Plasmid DNA Therapeutic Vaccine to Treat Cervical Intraepithelial Neoplasia Safety of GX-188E DNA Therapeutic Vaccine Administered by Electroporation to Cervical Intraepithelial Neoplasia Grade 3 Effect of Curcumin in Treatment of Squamous Cervical Intraepithelial Neoplasias (CINs) Study of SOR007 Ointment for Cervical Intraepithelial Neoplasia (CIN) Impact on Disease Relapse of HPV Vaccination in Women Treated With LEEP for Cervical Intraepithelial Neoplasia. HOPE9 Focal Ablation of Cervical Precancer Digital Imaging Aid for Assessment of Cervical Dysplasia Intravaginal Artesunate for the Treatment of HPV+ High Grade Cervical Intraepithelial Neoplasia (CIN2/3) TRICIN: Prospective Study on the Efficacy of Single Topical Trichloroacetic Acid (TCA) 85% in the Treatment of Cervical Intraepithelial Neoplasia (CIN 1/2) Hexaminolevulinate (HAL) Photodynamic Therapy (PDT) of Cervical Intraepithelial Neoplasia (CIN) Grade 1 Validation of Implementation of Cervical Dysplasia Treatment Modalities in HIV-Seropositive Women Vaginal Progesterone in the Treatment of Cervical Dysplasia Grade I and II Testing Use of Condoms on Regression of Cervical Intraepithelial Neoplasia Safety Study to Test the Safety of HspE7 and Poly-ICLC Given in Patients With Cervical Intraepithelial Neoplasia Can Alternative Treatment Have an Impact on Cervical Dysplasia? Forced Versus Spray Coagulation in Women Undergoing LLETZ-conization for Cervical Dysplasia: a Randomized Trial Efficacy and Safety Study of PGA (Poly-gamma Glutamic Acid) for Cervical Intraepithelial Neoplasia Oral Diindolylmethane (DIM) for the Treatment of Cervical Dysplasia A Phase II Single-arm Intervention Trial of Nelfinavir in Patients With Grade 2/3 or 3 Cervical Intraepithelial Neoplasia A Pilot Study to Evaluate Ultrasonic Surgical Aspiration as a Treatment Modality for Cervical Dysplasia Physical Cold Atmospheric Plasma for the Treatment of Cervical Intraepithelial Neoplasia Efficacy and Safety Study of BLS_ILB_E710c for the Fertile Women With Cervical Intraepithelial Neoplasia(CIN3) Cryotherapy vs. LEEP to Treat Cervical Intraepithelial Neoplasia (CIN) 2/3 Among HIV-positive Women An Alternative Treatment for Cervical Intraepithelial Neoplasia Using the Focal Loop Electrosurgical Excision Procedure

Brief Title

Immunohistochemical Staining of p16 for the Screening of Cervical Cancer

Official Title

Immunohistochemical Staining of p16 for the Screening of Cervical Cancer

Brief Summary

      Cyclin kinase inhibitor P16INK4A has overexpression in cervical cancer, and hence becoming an
      alternative method for cervical cancer screening. This study is to investigate the clinical
      value of P16INK4A and high-risk human papillomavirus (hrHPV) detection of cervical
      intraepithelial neoplasia (CIN) 2 or more severe lesions (CIN2+). All eligible participants
      accept P16INK4A testing, with cytology and/or hrHPV assay. P16INK4A immunohistochemical
      staining is performed on the retained specimens of cytology. The primary endpoint is the
      diagnostic accuracy of P16INK4A compared with cytology and/or hrHPV status based on histology
      results. The accuracy analysis includes sensitivity, specificity, negative predictive value
      and positive predictive value.

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

Diagnostic accuracy of p16 protein expression

Condition

Cervical Cancer Screening

Intervention

p16 protein expression

Study Arms / Comparison Groups

 Study group
Description:  All eligible participants as one group accept P16INK4A testing, with cytology and/or hrHPV assay.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Diagnostic Test

Estimated Enrollment

250

Start Date

November 26, 2020

Completion Date

November 26, 2020

Primary Completion Date

November 26, 2020

Eligibility Criteria

        Inclusion Criteria:

          -  Aged 18 years or older

          -  Signed an approved informed consents

          -  With sufficient cytology sample for p16 testing

          -  With definite results of cytology and/or high-risk human papillomavirus and cervical
             histology

        Exclusion Criteria:

          -  Not meeting all of the inclusion criteria

Gender

Female

Ages

21 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Lei Li, M.D., +8613911988831, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations

NCT ID

NCT04650711

Organization ID

CC-P16

Responsible Party

Sponsor-Investigator

Study Sponsor

Lei Li

Study Sponsor

Lei Li, M.D., Principal Investigator, Peking Union Medical College Hospital

Verification Date

November 2020