HPV Test of Urine and Self Collected Vaginal Samples for Cervical Cancer Screening Study
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| ClinicalTrials.gov Identifier: NCT03409471 |
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Recruitment Status : Unknown
Verified August 2018 by Jae Kwan Lee, Korea University Guro Hospital.
Recruitment status was: Recruiting
First Posted : January 24, 2018
Last Update Posted : August 24, 2018
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| Condition or disease | Intervention/treatment |
|---|---|
| ASC-US LSIL | Device: Flocked Swab Device: Cervical Brush Diagnostic Test: HPV assay |
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.
| Study Type : | Observational |
| Estimated Enrollment : | 300 participants |
| Observational Model: | Other |
| Time Perspective: | Cross-Sectional |
| Official Title: | Human Papillomavirus(HPV) Test of Urine and Self Collected Vaginal Samples for Cervical Cancer Screening Study |
| Actual Study Start Date : | May 4, 2018 |
| Estimated Primary Completion Date : | February 28, 2019 |
| Estimated Study Completion Date : | February 28, 2019 |
- Device: Flocked Swab
At the colposcopy clinic, vaginal self-sample will be collected with the Flocked Swab (Noble Bioscience, Inc., Korea).
- Device: Cervical Brush
Physician collected cervical sample will be collected also at the colposcopy center with the Cervical Brush (Noble Bioscience, Inc., Korea).
- Diagnostic Test: HPV assay
The hrHPV assay used, will be the Roche Cobas® 4800 HPV test, Anyplex™ II HPV HR detection kit and Realtime HPV HR-S Detection kit.
- Clinical accuracy [ Time Frame: Within 6 months after study completion ]Absolute sensitivity and specificity for finding underlying cervical intraepithelial neoplasia(CIN)2+ of HPV testing(Roche Cobas® 4800 HPV test, Anyplex™ II HPV HR detection kit and Realtime HPV HR-S Detection kit) on urine, self- and clinician-collected samples.
- Clinical accuracy [ Time Frame: Within 6 months after study completion ]Relative sensitivity and specificity of hrHPV testing on vaginal self-samples and urine sample vs clinician-collected samples.
- Analytical performance [ Time Frame: Within 6 months after study completion ]Concordance of the presence of HPV16, 18 and other high risk HPV genotyping results applied on urine, self- and clinician-collected samples
Biospecimen Retention: Samples With DNA
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| Ages Eligible for Study: | 20 Years to 60 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Gender Based Eligibility: | Yes |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03409471
| Contact: Jae Kwan Lee, MD, Ph.D. | 82-2-2626-3142 | jklee38@korea.ac.kr | |
| Contact: Hyun Woong Cho, MD | 82-2-2626-3147 | limpcho82@korea.ac.kr |
| Korea, Republic of | |
| Korea University Guro Hospital | Recruiting |
| Seoul, Korea, Republic of, 08308 | |
| Contact: Seung-hoe Song, MBE 82-2-2626-1635 ssessong@korea.ac.kr | |
| Contact: Ji-young Lee 82-2-2626-2279 ljy@kumc.or.kr | |
| Principal Investigator: Jae Kwan Lee, MD, Ph.D. | |
| Sub-Investigator: Jin Hwa Hong, MD, Ph.D. | |
| Sub-Investigator: Yung Taek Ouh, MD | |
| Sub-Investigator: Hyun-Woong Cho, MD | |
| Principal Investigator: | Jae Kwan Lee, MD, Ph.D. | Professor |
| Responsible Party: | Jae Kwan Lee, Professor, Korea University Guro Hospital |
| ClinicalTrials.gov Identifier: | NCT03409471 |
| Other Study ID Numbers: |
K2017-9243 (HPV Ur SELF) |
| First Posted: | January 24, 2018 Key Record Dates |
| Last Update Posted: | August 24, 2018 |
| Last Verified: | August 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | Yes |
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Urine Cervical Intraepithelial Neoplasia Self-Sampling HPV Testing |
Cervical Cancer Screening ASCUS LSIL |
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Uterine Cervical Neoplasms Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms |
Neoplasms by Site Neoplasms Uterine Cervical Diseases Uterine Diseases |