HPV Integration Testing for Human Papillomavirus-Positive... | NCT02576262

Studies
HPV Integration Testing for Human Papillomavirus-Positive Women

NCT02576262

Sponsor

Huazhong University of Science and Technology

Status

Unknown status

Last Update Posted

Jun 27, 2017Actual

Enrollment

1,200Estimated

Phase

Not provided

Conditions

Cervical Intraepithelial Neoplasia
Cervical Cancer

Interventions

TCT，HPV，colposcopic inspection

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

Jun 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2015

Primary Completion Date

Sep 2018Estimated

Completion Date

Sep 2020Estimated

First Submitted Date

Sep 22, 2015

First Submission Date that Met QC Criteria

Oct 12, 2015

First Posted Date

Oct 15, 2015Estimated

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

Jun 24, 2017

Last Update Posted Date

Jun 27, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ding Ma, Chief Physician, Huazhong University of Science and TechnologyPrincipal Investigator

Lead Sponsor

Huazhong University of Science and TechnologyOTHER

Collaborators

Not provided

Description Module

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.

Detailed Description

Not provided

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

1,200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HPV-positive women，30-65 years of age			Procedure: TCT，HPV，colposcopic inspection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TCT，HPV，colposcopic inspection	Procedure		HPV-positive women，30-65 years of age

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sensitivity and Specificity of the HPV integration screening test with comparison to HPV testing or TCT		14 Months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Danhui Weng, MD, PhD	Contact	+862783662681		weng.dh@gmail.com

Overall Officials

Name	Affiliation	Role
Ding Ma, MD, PhD	Huazhong University of Science and Technology	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology	Recruiting	Wuhan	Hubei	430030	China

Condition Browse Module

MeSH Terms

ID	Term
D002578	Uterine Cervical Dysplasia
D002583	Uterine Cervical Neoplasms

Ancestor Terms

ID	Term
D011230	Precancerous Conditions
D009369	Neoplasms
D002577	Uterine Cervical Diseases
D014591	Uterine Diseases

Browse Leaves

Not provided

Browse Branches

Not provided