HPV InfectionNCT06631495
All-cause and Diseases-specific Mortality of High-risk HPV Infection
An observational study of HPV Infection, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
The corresponding prevention strategies and treatment routes of HPV infection can be provided through investigating causes of death due to HPV infection and specialized diseases. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- HPV Infection
- What is being tested?
- Observation
- How many people
- 100,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2024to 1 Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Female participate in cervical cancer screening
Who may be able to join
- Female participate in at least once cervical cancer screening with clear information of HPV DNA test results;
- Having clear identification (ID number or others) that can be retrieved in the cause of death database.
Who cannot join
- Cases that do not fully meet all inclusion criteria are used as exclusion criteria.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking Union Medical College Hospital
Beijing, 100730
Lei Li, +86-13911988831, lileigh@163.com
About this study
The corresponding prevention strategies and treatment routes of HPV infection can be provided through investigating causes of death due to HPV infection and specialized diseases.
Read the detailed description
Anxiety and panic about HPV infection have become common phenomena in tumor screening. Transitional and useless diagnosis and treatment caused by HPV infection are also common, affecting women's physical and mental health and health economic level. If the investigators can understand the causes of death related to HPV infection and specialized diseases, the investigators can provide corresponding prevention strategies and treatment routes from the level of health policies and individual methods and mechanisms, and also alleviate the related panic caused by HPV infection.
- Conditions
- HPV Infection
- Being tested
- Observation
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
not available-observation study
| Study group | Role | What they receive |
|---|---|---|
| HPV infection | patients with HPV infection Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
HR-HPV infection AND all-cause and diseases-specific mortality
all-cause and diseases-specific mortality of HR-HPV infection
Measured: one year
Secondary outcomes (2)
time-period of HR-HPV infection AND all-cause and diseases-specific mortality
all-cause and diseases-specific mortality of time-period of HR-HPV infection
Measured: one year
HR-HPV type AND all-cause and diseases-specific mortality
all-cause and diseases-specific mortality of HR-HPV type
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start1 Oct 2024 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HPV InfectionStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 100,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lei Li, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06631495
- Sponsor's protocol ID
- HPV-ADM1
- Status last verified
- Aug 2024
- First submitted
- 29 Aug 2024
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- All-cause and Diseases-specific Mortality of High-risk HPV Infection
- ClinicalTrials.gov ID
- NCT06631495
- Acronym / sponsor ID
- HPV-ADM1
- Conditions
- HPV Infection
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100,000 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 8 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The corresponding prevention strategies and treatment routes of HPV infection can be provided through investigating causes of death due to HPV infection and specialized diseases.
Detailed description
Anxiety and panic about HPV infection have become common phenomena in tumor screening. Transitional and useless diagnosis and treatment caused by HPV infection are also common, affecting women's physical and mental health and health economic level. If the investigators can understand the causes of death related to HPV infection and specialized diseases, the investigators can provide corresponding prevention strategies and treatment routes from the level of health policies and individual methods and mechanisms, and also alleviate the related panic caused by HPV infection.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HPV infection | – | Other: Observationpatients with HPV infection |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Female participate in cervical cancer screening
Key inclusion criteria (2 listed)
- Female participate in at least once cervical cancer screening with clear information of HPV DNA test results;
- Having clear identification (ID number or others) that can be retrieved in the cause of death database.
Key exclusion criteria (1 listed)
- Cases that do not fully meet all inclusion criteria are used as exclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observationnot available-observation study | Other | HPV infection |
Primary outcome
HR-HPV infection AND all-cause and diseases-specific mortality
Time frame: one year
all-cause and diseases-specific mortality of HR-HPV infection
2 secondary outcomes
time-period of HR-HPV infection AND all-cause and diseases-specific mortality
Time frame: one year
HR-HPV type AND all-cause and diseases-specific mortality
Time frame: one year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HPV Infection, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Li, doctor (13911988831, lileigh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HR-HPV infection AND all-cause and diseases-specific mortality (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.