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
CRIS Registration Number |
KCT0003000 |
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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
Board Approval Status | Submitted approval |
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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 Person for Principal Investigator / Scientific Queries | |
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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
Study Site | Multi-center Number of center : 4 | |
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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
1. Source of Monetary/Material Support | |
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Organization Name | Ministry of Health & Welfare |
Organization Type | Government |
Project ID | HI17C2229 |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Koera University Guro Hospital |
Organization Type | Medical Institute |
7. Study Summary
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. |
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8. Study Design
Study Type | Interventional Study |
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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
Condition(s)/Problem(s) |
* (C00-D48)Neoplasms (C53.9)Malignant neoplasm of cervix uteri, unspecified |
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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)
Type of Primary Outcome | Not applicable | |
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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. |
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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
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | Not provided at time of Registration |
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