Cervical CancerNCT00889902
Molecular Markers in Cervical Cancer Screening in the Feasibility of the Mathematical Markov Model Analysis
An observational study of Cervical Cancer, run by Wuhan University at 1 site in China.
Trial summary
The purpose of this study is to: 1. make p16INK4A as a cervical cancer screening of tumor markers, cytology improve existing diagnostic sensitivity, specificity, repeatability and validity, so as to effectively prompted the early discovery and diagnosis of cervical cancer. 2. Read more about this study
- Who is it for?
- Ages 25 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Apr 2009to Jul 2011
- 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 25 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: residents of a certain town
Who may be able to join
- Married women aged 25 to 65-year-old with risk factors
- No tumor and pelvic radiation therapy history
- Non-pregnant women at present
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Ying J Huang contact
About this study
The purpose of this study is to:
- make p16INK4A as a cervical cancer screening of tumor markers, cytology improve existing diagnostic sensitivity, specificity, repeatability and validity, so as to effectively prompted the early discovery and diagnosis of cervical cancer.
- reduce screening costs, screening and benefits into quantitative evaluation, for our country to develop cervical cancer prevention and control strategy to provide a reliable theoretical basis.
Read the detailed description
- To carry out large-scale prospective randomized controlled clinical study to evaluate the "cytological molecular markers Detect + P16INK4A" methods of screening accuracy and reliability, as well as the screening method of the biological effects.
- Markov set up mathematical model of screening tests to quantify the inputs and the evaluation proceeds. With a view to optimize and perfect a simple, convenient, practical and efficient program of cervical cancer screening.
- Conditions
- Cervical Cancer
- Keywords
- Molecular Markers, Cervical Cancer, Screening, Makov
- Medical subject headings
- Uterine Cervical Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionJun 2010 (estimated)
- Study completionJul 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wuhan University
- Sponsor type
- University, hospital or other
- Investigators
- Hong B Cai, Doctor, Study director, gynecologic oncology department, Zhongnan Hospital of Wuhan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00889902
- Sponsor's protocol ID
- 320.6740
- Status last verified
- Apr 2009
- First submitted
- 27 Apr 2009
- Last updated
- 29 Apr 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Markers in Cervical Cancer Screening in the Feasibility of the Mathematical Markov Model Analysis
- ClinicalTrials.gov ID
- NCT00889902
- Acronym / sponsor ID
- 320.6740
- Conditions
- Cervical Cancer
- Keywords
- Molecular Markers, Cervical Cancer, Screening, Makov
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Wuhan UniversityUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Jun 2010 (estimated)
- Study completion
- Jul 2011 (estimated)
- First posted
- 29 Apr 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.
The purpose of this study is to:
- make p16INK4A as a cervical cancer screening of tumor markers, cytology improve existing diagnostic sensitivity, specificity, repeatability and validity, so as to effectively prompted the early discovery and diagnosis of cervical cancer.
- reduce screening costs, screening and benefits into quantitative evaluation, for our country to develop cervical cancer prevention and control strategy to provide a reliable theoretical basis.
Detailed description
- To carry out large-scale prospective randomized controlled clinical study to evaluate the "cytological molecular markers Detect + P16INK4A" methods of screening accuracy and reliability, as well as the screening method of the biological effects.
- Markov set up mathematical model of screening tests to quantify the inputs and the evaluation proceeds. With a view to optimize and perfect a simple, convenient, practical and efficient program of cervical cancer screening.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- residents of a certain town
Key inclusion criteria (3 listed)
- Married women aged 25 to 65-year-old with risk factors
- No tumor and pelvic radiation therapy history
- Non-pregnant women at present
Key exclusion criteria (0 listed)
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2009.
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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.
Ying J Huang contact
Hong B Cai, Doctor study director
gynecologic oncology department, Zhongnan Hospital of Wuhan 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 Wuhan 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 3 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 29 Apr 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hong B Cai, Doctor (0086-027-67813044, Chb2105@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
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 29 Apr 2009.