NCT02063152

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.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
300,000

participants targeted

Target at 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

January 1, 1995

Completed
19.1 years until next milestone

First Submitted

Initial submission to the registry

February 10, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 14, 2014

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Last Updated

August 17, 2017

Status Verified

August 1, 2017

Enrollment Period

25.9 years

First QC Date

February 10, 2014

Last Update Submit

August 14, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Time to the cancer diagnosis or the recurrence, the death, or the last date of follow-up, whichever came first

    up to 25 years

Study Arms (1)

Entire Taiwan women

Eligibility Criteria

Age20 Years - 130 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taiwan Cervical Cancer Prevention Monitoring Center

Taipei, 10055, Taiwan

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Chi-An Chen, MD

    Department of Obstetrics and Gynecology, College of Medicine, National Taiwan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hui-Chi Chen, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
25 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2014

First Posted

February 14, 2014

Study Start

January 1, 1995

Primary Completion

December 1, 2020

Last Updated

August 17, 2017

Record last verified: 2017-08

Locations