NCT05613283Active, not recruiting
Primary Cervical Cancer Screening by Self-sampling HPV Test
Source: ClinicalTrials.gov · Last updated 21 Dec 2023
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 17875 (estimated)
- First submitted
- 4 Nov 2022
- Start date
- 19 Nov 2022
- Primary completion date
- 31 Jul 2026
- Lead sponsor
- Peking University People's Hospital
- Diseases
- Cervical cancer
- NCT number
- NCT05613283
What you commit to
- Study type: Observational
- Planned participants: 17875
- From 19 Nov 2022 to the primary completion date, 31 Jul 2026
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- 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.
Other illness
- Those with known history of cervical cancer.
- Participants who participated in cervical cancer screening programs or underwent cervical cytology within 12 months.
Other
- Accuracy Verification:
- Subjects meeting any of the following criteria will be excluded:
- Known pregnant subjects.
- Participants who have undergone total hysterectomy.
- 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:
- Known pregnant subjects.
- Participants who have undergone total hysterectomy.
- Participants with poor compliance or researchers who believe that they are not suitable to participate in this study.
Who the study is looking for
- a. Females aged 21-65; b. have a history of sexual life; c. The patients were voluntarily enrolled and signed the informed consent.
Age in the registry: 21 years to 65 years · Sex: Female · Accepts healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University People's Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Hunan Provincial Maternal and Child Health Care Hospital Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| Chengdu Women's and Children's Central Hospital Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| Women's hospital school of medicine Zhejiang University Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Henan Cancer Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
| The Third Affiliated Hospital of Zhengzhou University Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.