DNA Cytometry for Cervical Cancer Screening in China

Cervical Cancer Clinical Trial

— DNACIC  

Official title:

Comparison of DNA Image Cytometry and Conventional Cytology for Cervical Cancer Screening in China

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00902551
• Other study ID #: NMU-200703-FC012
• Secondary ID: NJFY-2007-12901
• Status: Completed
• Phase: N/A
• First received: May 14, 2009
• Last updated: November 9, 2009
• Start date: January 2007
• Est. completion date: June 2009

Study information

• Verified date: November 2009
• Source: Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25000
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

• Currently or had been married

• Not pregnant

• Had an intact uterus with no prolapse

• Had no history of cervical cancer

• Living in China

Exclusion Criteria:

• Not willing to participate or finish the study at any time

• History of cervical surgeries

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Locations

Country	Name	City	State
China	Nanjing Maternal and Child Health Care Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing Medical University

Country where clinical trial is conducted

China, 

References & 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 R — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of cervical cancer.		From the testing performed by the investigator (0h) to one year follow-up period	Yes
Secondary	The rate of death.		One year follow-up period after screening.	Yes
Secondary	The incidence of cervical intraepithelial neoplasia.		From the screening (0h) to one year follow-up period	Yes
Secondary	Cervical inflammation		From the screening (0h) to one year follow-up period	Yes