NCT03178136

Brief Summary

It is universally accepted that the persistent infection of high-risk human papillomavirus(HR-HPV) is the cause of cervical intraepithelial neoplasias and cancer. Some researches indicate that the virus load may relate the extent of the disease. The objective of the study is to detect the virus load of 14 types HR-HPV among the participants, using a new HPV DNA hybrid capture technology,sequentially find the diagnostic significance of virus load of HPV.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2017

Longer than P75 for all trials

Geographic Reach
1 country

7 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 20, 2017

Completed
17 days until next milestone

First Posted

Study publicly available on registry

June 6, 2017

Completed
13 days until next milestone

Study Start

First participant enrolled

June 19, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

January 3, 2019

Status Verified

January 1, 2019

Enrollment Period

2 years

First QC Date

May 20, 2017

Last Update Submit

January 1, 2019

Conditions

Cervical Cancer

Keywords

HR-HPV opportunistic screeningvirus loadmulti-site

Outcome Measures

Primary Outcomes (1)

  • virus load

    virus load of 14 types HR-HPV

    1 day

Study Arms (2)

case group

There is no intervention in case group.

control group

The control group as the contrast for case group.

Eligibility Criteria

Age25 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The patients who are voluntary to accept screening with sexual life between the age of 25 to 65 are the target population of the study. The population who with uterectomy, cancer, other serious illness, physical examination are exclusive, the pregnant women are not exclusive.

You may qualify if:

  • The patients who are voluntary to accept screening with sexual life

You may not qualify if:

  • uterectomy, cancer, other serious illness, physical examination(pregnant women are not exclusive)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Cancer hospital of Anshan City

Anshan, Liaoning, China

Location

The second hospital of Chaoyang City

Chaoyang, Liaoning, China

Location

Dalian obstetrics and gynaecology hospital

Dalian, Liaoning, China

Location

The first affiliated hospital of Jinzhou Medical University

Jinzhou, Liaoning, China

Location

The first hospital of China Medical University

Shenyang, Liaoning, China

Location

Women's and children's hospital of Yingkou City

Yingkou, Liaoning, China

Location

Shenyang women's and children's hospital

Shenyang, Lioaning, China

Location

Related Publications (4)

  • Snijders PJ, van den Brule AJ, Meijer CJ. The clinical relevance of human papillomavirus testing: relationship between analytical and clinical sensitivity. J Pathol. 2003 Sep;201(1):1-6. doi: 10.1002/path.1433.

    PMID: 12950011BACKGROUND

  • Vorsters A, Van Keer S, Biesmans S, Hens A, De Coster I, Goossens H, Ieven M, Van Damme P. Long-Term Follow-up of HPV Infection Using Urine and Cervical Quantitative HPV DNA Testing. Int J Mol Sci. 2016 May 17;17(5):750. doi: 10.3390/ijms17050750.

    PMID: 27196899BACKGROUND

  • Wakeham K, Kavanagh K, Cuschieri K, Millan D, Pollock KG, Bell S, Burton K, Reed NS, Graham SV. HPV status and favourable outcome in vulvar squamous cancer. Int J Cancer. 2017 Mar 1;140(5):1134-1146. doi: 10.1002/ijc.30523.

    PMID: 27864932RESULT

  • Wang M, Hou B, Wang X, Han L, Shi Y, Zhang Y, Zhang L, Liu L, Jin F, Zhang Y. Diagnostic value of high-risk human papillomavirus viral load on cervical lesion assessment and ASCUS triage. Cancer Med. 2021 Apr;10(7):2482-2488. doi: 10.1002/cam4.3653. Epub 2021 Mar 7.

    PMID: 33682355DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

cervical cell

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Min Wang

    Shengjing Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

May 20, 2017

First Posted

June 6, 2017

Study Start

June 19, 2017

Primary Completion

June 1, 2019

Study Completion

June 1, 2022

Last Updated

January 3, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(7)