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DNA Cytometry for Cervical Cancer Screening in China (DNACIC)

This study has been completed.
Sponsor:
Information provided by:
Nanjing Medical University
ClinicalTrials.gov Identifier:
NCT00902551
First received: May 14, 2009
Last updated: November 9, 2009
Last verified: November 2009
  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 ] [ Designated as safety issue: Yes ]

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

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

Ages Eligible for Study:   20 Years to 65 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: May 14, 2009
Last Updated: November 9, 2009
Health Authority: China: Ethics Committee

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

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

ClinicalTrials.gov processed this record on November 27, 2014