DNA Cytometry for Cervical Cancer Screening in China

NCT ID: NCT00902551

Last Updated: 2009-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

25000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-01-31

Study Completion Date

2009-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Cervical Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Subjects underwent cervical sample DNA image cytometry

No interventions assigned to this group

2

Subjects underwent cervical sample conventional cytology

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Nanjing Medical University

Principal Investigators

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XiaoFeng Shen, MD

Role: STUDY_DIRECTOR

Nanjing Medical University

Locations

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Nanjing Maternal and Child Health Care Hospital

Nanjing, Jiangsu, China

Site Status

Countries

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China

References

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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.

Reference Type RESULT
PMID: 19825960 (View on PubMed)

Other Identifiers

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NJFY-2007-12901

Identifier Type: -

Identifier Source: secondary_id

NMU-200703-FC012

Identifier Type: -

Identifier Source: org_study_id

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