Records View

HPV test of URine and SElf-collected sampLes For cervical cancer screening study

Status Approved

  • First Submitted Date

    2018/04/02

  • Registered Date

    2018/07/13

  • Last Updated Date

    2018/06/11

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0003000
    Unique Protocol ID 2018AS0053
    Public/Brief Title HPV test of URine and SElf-collected sampLes For cervical cancer screening study
    Scientific Title HPV test of URine and SElf-collected sampLes For cervical cancer screening study
    Acronym HPV URSELF
    MFDS Regulated Study No
    IND/IDE Protocol No
    Registered at Other Registry Yes
    Name of Registry / Registration Number ClinicalTrials.gov-NCT03409471
    Healthcare Benefit Approval Status Not applicable
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number 2 0 1 8 A S 0 0 5 3
    Approval Date 2018-02-27
    Institutional Review Board Name Korea University Ansan Hospital IRB
    Institutional Review Board Address 123, Jeokgeum-ro, Danwon-gu, Ansan-si, Gyeonggi-do
    Institutional Review Board Telephone 031-412-6514
    Data Monitoring Committee No
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Jae Kwan Lee
    Title Professor
    Telephone +82-2-2626-3142
    Affiliation Koera University Guro Hospital
    Address 148 Gurodong-ro, Guro-Gu, Seoul 152-703, Korea
    Contact Person for Public Queries
    Name Hyun Woong Cho
    Title Clinical Instructor
    Telephone +82-2-2626-3147
    Affiliation Koera University Guro Hospital
    Address 148 Gurodong-ro, Guro-Gu, Seoul 152-703, Korea
    Contact Person for Updating Information
    Name Hyun Woong Cho
    Title Clinical Instructor
    Telephone +82-2-2626-3147
    Affiliation Koera University Guro Hospital
    Address 148 Gurodong-ro, Guro-Gu, Seoul 152-703, Korea
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Multi-center Number of center : 4
    Overall Recruitment Status Recruiting
    Date of First Enrollment 2018-04-02 Actual
    Target Number of Participant 300
    Primary Completion Date 2020-04-01 , Anticipated
    Study Completion Date 2020-04-01 , Anticipated
    Recruitment Status by Participating Study Site 1
    Name of Study Korea University Ansan Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2018-06-04 ,
    Recruitment Status by Participating Study Site 2
    Name of Study Cheil General Hospital and Women's Healthcare Center
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2018-06-18 ,
    Recruitment Status by Participating Study Site 3
    Name of Study Samsung Medical Center
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2018-06-18 ,
    Recruitment Status by Participating Study Site 4
    Name of Study Koera University Guro Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2018-04-02 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Ministry of Health & Welfare
    Organization Type Government
    Project ID HI17C2229
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Koera University Guro Hospital
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    This study is a prospective observational study of human papillomavirus (HPV) testing using urine and self-collected vaginal samples for women who have atypical squamous cells of undetermined significance(ASCUS) or low grade squamous intraepithelial lesion(LSIL) on Pap test. Among women who are diagnosed with ASCUS and LSIL, HPV test is performed by collecting urine and self-collected vaginal sample in standardized condition before colposcopy, and evaluation will be performed as a primary screening test with cytology triage.
    
    The samples are collected from patients referred to colposcopy because of prior cervical abnormalities on Pap test such as ASCUS and LSIL. The patient takes at home urine samples on the morning of visit to the colposcopy center. At the colposcopy center, self-collected vaginal samples are taken by the patient herself with a plastic brush (Flocked Swab, manufactured by Noble Bioscience, Inc.). Finally, the gynecologist takes a cervical sample with a plastic brush (Cervical Brush, manufactured by Noble Bioscience, Inc.).
    
    Physician collected cervical samples, self-collected vaginal samples and urine samples are used to perform HPV testing with Roche Cobas® 4800 HPV test, Anyplex™ II HPV HR detection kit and Realtime HPV HR-S Detection kit.
    
    The Anyplex™ II HPV HR detection kit (manufactured by Seegene. Inc, Korea) is a new, multiplex, real-time polymerase chain reaction assay to detect individual 14 high-risk. (HR) human papillomavirus (HPV) types in a single tube.
    
    The Roche Cobas® 4800 HPV test (manufactured by Cobas) is a novel molecular method based on real-time PCR (RT-PCR), with a fully automated system allowing quick and efficient sample processing. Cobas can detect the human papillomavirus type 16(HPV16), the human papillomavirus type 18(HPV18), 12 other high-risk HPVs (hrHPVs) (HPV31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66, and -68, as a pooled result), and the β-globin control independently in the same PCR.
    
    Realtime HPV HR-S Detection kit (manufactured by Sejong Biomed Co, Korea) is a new, real-time polymerase chain reaction assay to detect HPV 16, HPV 18, 12 other high-risk HPVs (HPV31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66, and -68). Real-time HPV HR-S Detection Kit is based on accurate real-time PCR method as described, and it can detect 14 kinds of HPV type detection in a single test (HPV 16/18 genotype and others (UDG) -dUTP) system for the prevention of contamination, and a control agent (hemoglobin DNA, a human-derived DNA) as a whole process control was introduced into a high-risk genotype (12 genotypes other than HPV 16/18). It has high sensitivity and specificity for detection of high risk genotypes by increasing the reliability of the results.
    
    The main goal of this study is to determine whether HPV testing using urine and self-collected sample is sensitive to detecting precancerous lesions such as cervical intraepithelial neoplasia(CIN)2/3 in patients diagnosed with ASCUS and LSIL on the Pap test. The colposcopy and histological findings will be used as the gold standard. In addition, the relative sensitivity and specificity for detecting HPV16, HPV18 and high risk HPV will be determined for each of the three HPV tests using urine and self-collected samples compared with the HPV tests using physician-collected samples.
  • 8. Study Design

    Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
    Study Type Interventional Study
    Study Purpose
    Diagnosis
    Phase Not applicable
    Intervention Model Parallel  
    Blinding/Masking Open
    Allocation Not Applicable
    Intervention Type Medical Device  
    Intervention Description
    The samples are collected from patients referred to colposcopy because of prior cervical abnormalities on Pap test such as ASCUS and LSIL. The patient takes at home urine samples on the morning of visit to the colposcopy center. At the colposcopy center, vaginal self-samples are taken by the patient herself: one with a plastic brush (Flocked Swab, Noble Bioscience, Inc.). Finally, the gynecologist takes a cervical sample with a plastic brush (Cervical Brush, Noble Bioscience, Inc.). 
    
    Physician collected cervical samples, self-collected vaginal samples and urine samples are used to perform HPV testing with Roche Cobas 4800 HPV test, Anyplex II HPV HR detection kit and Realtime HPV HR-S Detection kit.
    Number of Arms 3
    Arm 1

    Arm Label

    experimental group(self collected samples)

    Target Number of Participant

    300

    Arm Type

    Experimental

    Arm Description

    The samples are collected from patients referred to colposcopy because of prior cervical abnormalities on Pap test such as ASCUS and LSIL. The patient takes at home urine samples on the morning of visit to the colposcopy center. At the colposcopy center, vaginal self-samples are taken by the patient herself: one with a plastic brush (Flocked Swab, Noble Bioscience, Inc.). Finally, the gynecologist takes a cervical sample with a plastic brush (Cervical Brush, Noble Bioscience, Inc.). 
    
    Physician collected cervical samples, self-collected vaginal samples and urine samples are used to perform HPV testing with Roche Cobas 4800 HPV test, Anyplex II HPV HR detection kit and Realtime HPV HR-S Detection kit.
    Arm 2

    Arm Label

    experimental group(urine samples)

    Target Number of Participant

    300

    Arm Type

    Experimental

    Arm Description

    The samples are collected from patients referred to colposcopy because of prior cervical abnormalities on Pap test such as ASCUS and LSIL. The patient takes at home urine samples on the morning of visit to the colposcopy center. At the colposcopy center, vaginal self-samples are taken by the patient herself: one with a plastic brush (Flocked Swab, Noble Bioscience, Inc.). Finally, the gynecologist takes a cervical sample with a plastic brush (Cervical Brush, Noble Bioscience, Inc.). 
    
    Physician collected cervical samples, self-collected vaginal samples and urine samples are used to perform HPV testing with Roche Cobas 4800 HPV test, Anyplex II HPV HR detection kit and Realtime HPV HR-S Detection kit.
    Arm 3

    Arm Label

    reference group(clinician collected samples

    Target Number of Participant

    300

    Arm Type

    Active comparator

    Arm Description

    The samples are collected from patients referred to colposcopy because of prior cervical abnormalities on Pap test such as ASCUS and LSIL. The patient takes at home urine samples on the morning of visit to the colposcopy center. At the colposcopy center, vaginal self-samples are taken by the patient herself: one with a plastic brush (Flocked Swab, Noble Bioscience, Inc.). Finally, the gynecologist takes a cervical sample with a plastic brush (Cervical Brush, Noble Bioscience, Inc.). 
    
    Physician collected cervical samples, self-collected vaginal samples and urine samples are used to perform HPV testing with Roche Cobas 4800 HPV test, Anyplex II HPV HR detection kit and Realtime HPV HR-S Detection kit.
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (C00-D48)Neoplasms 
       (C53.9)Malignant neoplasm of cervix uteri, unspecified 
    Rare Disease No
    Inclusion Criteria

    Gender

    Female

    Age

    20Year~60Year

    Description

    Women with previous abnormal Pap test results (ASCUS, LSIL)
    Women between the ages of 20 and 60
    Exclusion Criteria
    Hysterectomised women
    Women with known pregnancy
    Non-consenting women
    Women that are not able to understand and to sign the informed consent
    Women who diagnosed and treated for cervical cancer or other malignancies
    Concurrent diseases that are immunosuppressed or require the use of immune-suppressants
    Healthy Volunteers No
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome Not applicable
    Primary Outcome(s) 1
    Outcome
    efficacy of HPV test for detecting CIN 2 or worse, by collection method and different HPV test
    Timepoint
    The rusults of study will be assesed by taking clinicina-collectes, self-collected and urine sample before undergoing biosy.
    Secondary Outcome(s) 1
    Outcome
    Concordance of the presence of HPV16, 18 and other high risk HPV genotyping results applied on urine, self- and clinician-collected samples
    Timepoint
    The rusults of study will be assesed by taking clinicina-collectes, self-collected and urine sample before undergoing biosy.
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered No
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement Not provided at time of Registration
화면 최상단으로 이동

TOP

BOTTOM

화면 최하단으로 이동