Cervical CancerDNACICNCT00902551
DNA Cytometry for Cervical Cancer Screening in China
An observational study of Cervical Cancer, run by Nanjing Medical University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 20 to 65 years, women only
- Conditions the study is for
- Cervical Cancer
- How many people
- 25,000 participants
- Where
- 1 siteChina
- Study dates
- Jan 2007to Jun 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Healthy women
Who may be able to join
- Currently or had been married
- Not pregnant
- Had an intact uterus with no prolapse
- Had no history of cervical cancer
- Living in China
Who cannot join
- Not willing to participate or finish the study at any time
- History of cervical surgeries
Trial locations and contacts
1 site in 1 country.
China1 site
Nanjing Maternal and Child Health Care Hospital
Nanjing, Jiangsu, 210004
About this study
Official title: Comparison of DNA Image Cytometry and Conventional Cytology 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.
- Conditions
- Cervical Cancer
- Keywords
- DNA cytometry, Cytology, Diagnosis accuracy
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Subjects underwent cervical sample DNA image cytometry | |
| 2 | Subjects underwent cervical sample conventional cytology |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of cervical cancer.
Measured: From the testing performed by the investigator (0h) to one year follow-up period
Secondary outcomes (3)
The rate of death.
Measured: One year follow-up period after screening.
The incidence of cervical intraepithelial neoplasia.
Measured: From the screening (0h) to one year follow-up period
Cervical inflammation
Measured: From the screening (0h) to one year follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2009 (estimated)
- Study startJan 2007
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 25,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Investigators
- XiaoFeng Shen, MD, Study director, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00902551
- Sponsor's protocol ID
- NMU-200703-FC012
- Other IDs
- NJFY-2007-12901
- Acronym
- DNACIC
- Status last verified
- Nov 2009
- First submitted
- 14 May 2009
- Last updated
- 10 Nov 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19825960
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of DNA Image Cytometry and Conventional Cytology for Cervical Cancer Screening in China
- ClinicalTrials.gov ID
- NCT00902551
- Acronym / sponsor ID
- DNACIC / NMU-200703-FC012
- Conditions
- Cervical Cancer
- Keywords
- DNA cytometry, Cytology, Diagnosis accuracy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25,000 participants (actual)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 15 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Subjects underwent cervical sample DNA image cytometry |
| 2 | – | –Subjects underwent cervical sample conventional cytology |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy women
Key inclusion criteria (5 listed)
- Currently or had been married
- Not pregnant
- Had an intact uterus with no prolapse
- Had no history of cervical cancer
- Living in China
Key exclusion criteria (2 listed)
- Not willing to participate or finish the study at any time
- History of cervical surgeries
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The incidence of cervical cancer.
Time frame: From the testing performed by the investigator (0h) to one year follow-up period
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2009.
- Results publication: PubMed 19825960Tong 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
XiaoFeng Shen, MD study director
Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Cancer, run by Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of cervical cancer. (time frame: From the testing performed by the investigator (0h) to one year follow-up period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00902551, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2009.