Trial Title:
Primary Cervical Cancer Screening by Self-sampling HPV Test
NCT ID:
NCT05613283
Condition:
Human Papillomavirus Infection
Cervical Cancer
Negative For Intraepithelial Lesion Or Malignancy
Atypical Squamous Cells of Undetermined Significance
Atypical Squamous Cells, Cannot Rule Out High-grade Squamous Intraepithelial Lesion
Cervical Squamous Intraepithelial Lesion
Low-Grade Squamous Intraepithelial Lesions
High-Grade Squamous Intraepithelial Lesions
Cervical Intraepithelial Neoplasia Grade I
Cervical Intraepithelial Neoplasia Grade II
Cervical Intraepithelial Neoplasia, Grade III
Atypical Glandular Cells
Atypical Glandular Cells Not Otherwise Specified
Atypical Glandular Cells, Favor Neoplastic
Cervical Squamous Cell Carcinoma
Adenocarcinoma in Situ
Cervical Adenocarcinoma
Conditions: Official terms:
Papillomavirus Infections
Carcinoma, Squamous Cell
Adenocarcinoma
Neoplasms
Uterine Cervical Neoplasms
Carcinoma in Situ
Uterine Cervical Dysplasia
Squamous Intraepithelial Lesions of the Cervix
Adenocarcinoma in Situ
Atypical Squamous Cells of the Cervix
Conditions: Keywords:
Self-sampling HPV testing
Human papilloma virus
Cervical cancer
Study type:
Observational
Overall status:
Active, not recruiting
Study design:
Time perspective:
Prospective
Summary:
Cervical cancer seriously threatens women's health and HPV infection is the main cause of
cervical cancer. Traditionally, Cervical cancer screening is based on cervical exfoliated
cell samples collected by health care provider, which is labor consuming and the coverage
and compliance are both relatively low in some areas. Non-invasive hrHPV self-sampling
test appears to be more acceptable and may improve the HPV screening coverage. This study
aims to evaluate the clinical performance of a newly developed urine/vaginal
self-sampling hrHPV test in Cervical cancer screening.
Detailed description:
This study is a prospective multi-center clinical trial in China. Eligible participants
are cervical cancer screening population who meet the enrollment criterias. All the
participants are required to provide urine and vaginal samples by self-sampling, as well
as the cervical exfoliated cell samples (by HCP). Participants may undergo colposcopy
examination depending on the test results, and they will be followed up for three years.
The high-risk human papillomavirus nucleic acid detection kit (PCR-fluorescent probe
method) developed by New Horizon Co., Ltd . is suitable for in vitro qualitative
detection of 14 types of high-risk HPV ( 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59,
66, 68) nucleic acid.
The clinical performance of the self-sampling test will be assessed base on the following
outcomes:
1. The sensitivity for detecting CIN2+
2. The specificity in non-CIN2+ population
3. The risk of developing CIN2+ in test positive cohort and test negative cohort
4. The accuracy of detecting hrHPV
Criteria for eligibility:
Study pop:
The population of clinical validity verification is all screening population, that is,
women who need to undergo routine cervical cancer screening and the results of cervical
cytology are unknown; Accuracy verification needs to include part of the screening
population and part of the outpatient population, that is, women who intend or need to
undergo colposcopy or cervical cancer screening for clinical visits.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- a. Females aged 21-65; b. have a history of sexual life; c. The patients were
voluntarily enrolled and signed the informed consent.
Exclusion Criteria:
- Accuracy Verification:
Subjects meeting any of the following criteria will be excluded:
1. Known pregnant subjects.
2. Participants who have undergone total hysterectomy.
3. Participants who have received cervical resection therapy or ablative therapy within
12 months, such as cryo, laser, microwave, coagulation, cryotherapy, LEEP, large
loop electrosurgery (LLETZ), cold knife conization (CKC), laser conization, or
ablation.
4. Participants with poor compliance or researchers who believe that they are not
suitable to participate in this study.
- Primary screening use:
Subjects meeting any of the following criteria will be excluded:
1. Known pregnant subjects.
2. Participants who have undergone total hysterectomy.
3. Participants who have received cervical resection therapy or ablative therapy within
12 months, such as cryo, laser, microwave, coagulation, cryotherapy, LEEP, large
loop electrosurgery (LLETZ), cold knife conization (CKC), laser conization, or
ablation.
4. Those with known history of cervical cancer.
5. Participants who participated in cervical cancer screening programs or underwent
cervical cytology within 12 months.
6. Participants with poor compliance or researchers who believe that they are not
suitable to participate in this study.
Gender:
Female
Gender based:
Yes
Gender description:
Based on biological sex
Minimum age:
21 Years
Maximum age:
65 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Peking University People's Hospital
Address:
City:
Beijing
Country:
China
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Country:
China
Facility:
Name:
The Third Affiliated Hospital of Zhengzhou University
Address:
City:
Zhengzhou
Country:
China
Facility:
Name:
Hunan Provincial Maternal and Child Health Care Hospital
Address:
City:
Changsha
Country:
China
Facility:
Name:
Chengdu Women's and Children's Central Hospital
Address:
City:
Chengdu
Country:
China
Facility:
Name:
Women's Hospital School Of Medicine Zhejiang University
Address:
City:
Hangzhou
Country:
China
Start date:
November 19, 2022
Completion date:
August 31, 2027
Lead sponsor:
Agency:
Peking University People's Hospital
Agency class:
Other
Collaborator:
Agency:
BeijingNewBiorayTechnologyCo.,Ltd.
Agency class:
Other
Collaborator:
Agency:
Hangzhou Newhorizon Health Technology Co., Ltd.
Agency class:
Other
Source:
Peking University People's Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05613283
