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DNA Cytometry for Cervical Cancer Screening in China (DNACIC)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00902551
First Posted: May 15, 2009
Last Update Posted: November 10, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Nanjing Medical University
  Purpose
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.

Condition
Cervical Cancer

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Comparison of DNA Image Cytometry and Conventional Cytology for Cervical Cancer Screening in China

Resource links provided by NLM:


Further study details as provided by Nanjing Medical University:

Primary Outcome Measures:
  • The incidence of cervical cancer. [ Time Frame: From the testing performed by the investigator (0h) to one year follow-up period ]

Secondary Outcome Measures:
  • The rate of death. [ Time Frame: One year follow-up period after screening. ]
  • The incidence of cervical intraepithelial neoplasia. [ Time Frame: From the screening (0h) to one year follow-up period ]
  • Cervical inflammation [ Time Frame: From the screening (0h) to one year follow-up period ]

Biospecimen Retention:   Samples With DNA
Cervical samples were taken through cervical brush. Feulgen method is used to determine the amount of DNA.

Enrollment: 25000
Study Start Date: January 2007
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Subjects underwent cervical sample DNA image cytometry
2
Subjects underwent cervical sample conventional cytology

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Healthy women
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00902551


Locations
China, Jiangsu
Nanjing Maternal and Child Health Care Hospital
Nanjing, Jiangsu, China, 210004
Sponsors and Collaborators
Nanjing Medical University
Investigators
Study Director: XiaoFeng Shen, MD Nanjing Medical University
  More Information

Publications:
Responsible Party: XiRong Guo, Nanjing Medical University
ClinicalTrials.gov Identifier: NCT00902551     History of Changes
Other Study ID Numbers: NMU-200703-FC012
NJFY-2007-12901
First Submitted: May 14, 2009
First Posted: May 15, 2009
Last Update Posted: November 10, 2009
Last Verified: November 2009

Keywords provided by Nanjing Medical University:
DNA cytometry
Cytology
Diagnosis accuracy

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female