DNA Cytometry for Cervical Cancer Screening in China
DNACIC
Comparison of DNA Image Cytometry and Conventional Cytology for Cervical Cancer Screening in China
2 other identifiers
observational
25,000
1 country
1
Brief Summary
Very few screenings of any kind will be possible during a woman's lifetime in most low-resource regions, where 80% of the half-million global cases of cervical cancer occur every year. Although a single round of human papillomavirus (HPV) testing was associated with a significant decline in the rate of advanced cervical cancers and associated deaths, whether other methods like as DNA image cytometry can be used as an more accurate means than others in screening cervical cancer or not is yet to be verified. In addition, the accuracy of both DNA image cytometry and conventional cytology is not well known. The investigators hypothesized that DNA image cytometry was superior in screening cervical cancer than conventional cytology.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2007
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2007
CompletedFirst Submitted
Initial submission to the registry
May 14, 2009
CompletedFirst Posted
Study publicly available on registry
May 15, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedNovember 10, 2009
November 1, 2009
2.4 years
May 14, 2009
November 9, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The incidence of cervical cancer.
From the testing performed by the investigator (0h) to one year follow-up period
Secondary Outcomes (3)
The rate of death.
One year follow-up period after screening.
The incidence of cervical intraepithelial neoplasia.
From the screening (0h) to one year follow-up period
Cervical inflammation
From the screening (0h) to one year follow-up period
Study Arms (2)
1
Subjects underwent cervical sample DNA image cytometry
2
Subjects underwent cervical sample conventional cytology
Eligibility Criteria
Healthy women
You may qualify if:
- Currently or had been married
- Not pregnant
- Had an intact uterus with no prolapse
- Had no history of cervical cancer
- Living in China
You may not qualify if:
- Not willing to participate or finish the study at any time
- History of cervical surgeries
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nanjing Maternal and Child Health Care Hospital
Nanjing, Jiangsu, 210004, China
Related Publications (1)
Tong H, Shen R, Wang Z, Kan Y, Wang Y, Li F, Wang F, Yang J, Guo X; Mass Cervical Cancer Screening Regimen Group. DNA ploidy cytometry testing for cervical cancer screening in China (DNACIC Trial): a prospective randomized, controlled trial. Clin Cancer Res. 2009 Oct 15;15(20):6438-45. doi: 10.1158/1078-0432.CCR-09-1689. Epub 2009 Oct 13.
PMID: 19825960RESULT
Biospecimen
Cervical samples were taken through cervical brush. Feulgen method is used to determine the amount of DNA.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
XiaoFeng Shen, MD
Nanjing Medical University
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 14, 2009
First Posted
May 15, 2009
Study Start
January 1, 2007
Primary Completion
June 1, 2009
Study Completion
June 1, 2009
Last Updated
November 10, 2009
Record last verified: 2009-11