NCT02576262

Brief Summary

Papanicolaou (Pap) triage, with high specificity, has been recommended for primary Human papillomavirus (HPV) testing but is flawed by poor sensitivity and cytologist dependence. the investigators evaluated the potential role of HPV Integration detection in cervical exfoliated cells in HPV-positive women from a clinic-based population.

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
1,200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

September 1, 2015

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

September 22, 2015

Completed
23 days until next milestone

First Posted

Study publicly available on registry

October 15, 2015

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

June 27, 2017

Status Verified

June 1, 2017

Enrollment Period

3 years

First QC Date

September 22, 2015

Last Update Submit

June 24, 2017

Conditions

Cervical Intraepithelial NeoplasiaCervical Cancer

Outcome Measures

Primary Outcomes (1)

  • Sensitivity and Specificity of the HPV integration screening test with comparison to HPV testing or TCT

    14 Months

Study Arms (1)

HPV-positive women，30-65 years of age

Procedure: TCT，HPV，colposcopic inspection

Interventions

TCT，HPV，colposcopic inspectionPROCEDURE
HPV-positive women，30-65 years of age

Eligibility Criteria

Age30 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

participants who visited the gynecologic clinic of hospital for various gynecologic disorders and underwent primary HPV testing were prospectively recruited

You may qualify if:

  • Women aged 30-65 years old visiting the gynecologic clinic of hospital

You may not qualify if:

  • Not providing informed consent
  • previously confirmed CIN, cervical cancer, or other malignancies
  • previous therapeutic procedure to cervix
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

RECRUITING

MeSH Terms

Conditions

Uterine Cervical DysplasiaUterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by Site

Study Officials

  • Ding Ma, MD, PhD

    Huazhong University of Science and Technology

    STUDY CHAIR

Central Study Contacts

Danhui Weng, MD, PhD

CONTACT

+862783662681weng.dh@gmail.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Physician

Study Record Dates

First Submitted

September 22, 2015

First Posted

October 15, 2015

Study Start

September 1, 2015

Primary Completion

September 1, 2018

Study Completion

September 1, 2020

Last Updated

June 27, 2017

Record last verified: 2017-06

Locations

CN(1)