102 Annual Pap Smear Screening Database Maintenance Project | NCT02063152

Studies
102 Annual Pap Smear Screening Database Maintenance Project

NCT02063152

Sponsor

National Taiwan University Hospital

Status

Unknown status

Last Update Posted

Aug 17, 2017Actual

Enrollment

300,000Estimated

Phase

Not provided

Conditions

Cancer
Human Papillomavirus

Interventions

Not provided

Countries

Taiwan

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 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

Jan 1995

Primary Completion Date

Dec 2020Estimated

Completion Date

Not provided

First Submitted Date

Feb 10, 2014

First Submission Date that Met QC Criteria

Feb 13, 2014

First Posted Date

Feb 14, 2014Estimated

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

Aug 14, 2017

Last Update Posted Date

Aug 17, 2017Actual

Description Module

Brief Summary

This study aimed to evaluate the subsequent cancer risks, including gynecological cancers and malignancies at other sites, after the detection of screening positives and the diagnosis for primary cervical cancer.

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

Yes

Target Follow-Up Duration

25 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300,000Estimated

Label	Type	Description	Intervention Names
Entire Taiwan women

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to the cancer diagnosis or the recurrence, the death, or the last date of follow-up, whichever came first		up to 25 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Citizens in Taiwan
Women who attended screening, or who were diagnosed as cervical cancer
Women who did not attend screening for at least 6 years

Exclusion Criteria:

Women died before the follow-up initiation
Women who had received hysterectomy before the follow-up initiation

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

130 Years

Standard Ages

AdultOlder Adult

Study Population

Women attended screening and found abnormal results, and women who were diagnosed as cervical cancer were the main study population. Women who did not attend screening for at least 6 years were also included.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hui-Chi Chen, PhD	Contact	+886 2 23910409	20	d90842001@ntu.edu.tw

Overall Officials

Name	Affiliation	Role
Chi-An Chen, MD	Department of Obstetrics and Gynecology, College of Medicine, National Taiwan University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Taiwan Cervical Cancer Prevention Monitoring Center	Recruiting	Taipei		10055	Taiwan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29770625	Derived	Tai YJ, Chen YY, Hsu HC, Chiang CJ, You SL, Chen CA, Cheng WF; Taiwan Cervical Cancer Control Task Force. Risks of cervical intraepithelial neoplasia grade 3 or invasive cancers in ASCUS women with different management: a population-based cohort study. J Gynecol Oncol. 2018 Jul;29(4):e55. doi: 10.3802/jgo.2018.29.e55. Epub 2018 Mar 20.