All-cause and Diseases-specific Mortality of High-risk HP... | NCT06631495

Studies
All-cause and Diseases-specific Mortality of High-risk HPV Infection

NCT06631495

Sponsor

Peking Union Medical College Hospital

Status

Not yet recruiting

Last Update Posted

Oct 8, 2024Actual

Enrollment

100,000Estimated

Phase

Not provided

Conditions

HPV Infection

Interventions

Observation

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2024

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2024Estimated

Primary Completion Date

Oct 1, 2026Estimated

Completion Date

Oct 1, 2027Estimated

First Submitted Date

Aug 29, 2024

First Submission Date that Met QC Criteria

Oct 6, 2024

First Posted Date

Oct 8, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 6, 2024

Last Update Posted Date

Oct 8, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HPV infection		patients with HPV infection	Other: Observation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Observation	Other	not available-observation study	HPV infection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
HR-HPV infection AND all-cause and diseases-specific mortality	all-cause and diseases-specific mortality of HR-HPV infection	one year

Secondary Outcomes

Measure	Description	Time Frame
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	one year
HR-HPV type AND all-cause and diseases-specific mortality

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

Cases that do not fully meet all inclusion criteria are used as exclusion criteria.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Female participate in cervical cancer screening

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Li, doctor	Contact	13911988831		lileigh@163.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking Union Medical College Hospital		Beijing		100730	China

Condition Browse Module

MeSH Terms

ID	Term
D030361	Papillomavirus Infections

Ancestor Terms

ID	Term
D015229	Sexually Transmitted Diseases, Viral
D012749	Sexually Transmitted Diseases
D003141	Communicable Diseases
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019370	Observation

Ancestor Terms

ID	Term
D008722	Methods
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided