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Completed

NCT Number: NCT00902551

DNA Cytometry for Cervical Cancer Screening in China

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.

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Key information

Conditions

Cervical Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

20 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

Nanjing Maternal and Child Health Care Hospital

Nanjing, Jiangsu, 210004, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. The incidence of cervical cancer.

    Time frame: From the testing performed by the investigator (0h) to one year follow-up period

Secondary outcomes

  1. The rate of death.

    Time frame: One year follow-up period after screening.

  2. The incidence of cervical intraepithelial neoplasia.

    Time frame: From the screening (0h) to one year follow-up period

  3. Cervical inflammation

    Time frame: From the screening (0h) to one year follow-up period

Sponsors and collaborators

Lead sponsor

Nanjing Medical University

Other

Registry information

Official study title

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

Acronym: DNACIC

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
May 15, 2009
Registry last updated
Nov 10, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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