Cervical CancerNCT01015079
The Association Between Cervical Cancer Screening and Cancer Occurrence
An observational study of Cervical Cancer and Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
To investigate the protective effect of cervical cancer incidence and mortality by screening attending frequency or screening pattern, and to evaluate the possible risk of developing malignancies among women with cervical lesions, inflammation or infection. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer, Cancer
- How many people
- 6,000,000 participants
- Where
- 1 siteTaiwan
- Study dates
- Nov 2009to not given
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The entire Taiwan women with their information obtained from several national registries.
The eligibility criteria in the proposal are specified in different part of analyses respectively, which are briefly listed below:
Part I:
- Include women covered by national screening program and they did not have previous cervical cancer history before the study initiate date.
Part II:
- Include women ever participated cervical cancer screening and exclude women with previous cervical cancer history before screening attending.
Part III:
- Include women without previous cervical cancer history before the follow-up initiation.
Part IV:
- Include women without previous cervical cancer history before the follow-up initiation.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taiwan Cervical Cancer Screening Task Force
Taipei, 10055
About this study
Official title: The Association Between Cervical Cancer Screening Participation and Corresponding Results and Subsequent Cancer Occurrence and Death
To investigate the protective effect of cervical cancer incidence and mortality by screening attending frequency or screening pattern, and to evaluate the possible risk of developing malignancies among women with cervical lesions, inflammation or infection.
- Conditions
- Cervical Cancer, Cancer
- Keywords
- Pap smear screening
- Medical subject headings
- Uterine Cervical Neoplasms, 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 |
|---|---|---|
| Entire Taiwan women | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2009 (estimated)
- Study startNov 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 National Taiwan University HospitalThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 6,000,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health, Executive Yuan, R.O.C. (Taiwan)
- Investigators
- Chi-An Chen, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01015079
- Sponsor's protocol ID
- 200910043R
- Status last verified
- Nov 2009
- First submitted
- 16 Nov 2009
- Last updated
- 17 Nov 2009
- Results posted
- No
Publications
Cheng WF, Chen YL, You SL, Chen CJ, Chen YC, Hsieh CY, Chen CA. Risk of gynaecological malignancies in cytologically atypical glandular cells: follow-up study of a nationwide screening population. BJOG. 2011 Jan;118(1):34-41. doi: 10.1111/j.1471-0528.2010.02769.x. Epub 2010 Nov 4.
PubMed 21054764
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Cervical Cancer Screening Participation and Corresponding Results and Subsequent Cancer Occurrence and Death
- ClinicalTrials.gov ID
- NCT01015079
- Acronym / sponsor ID
- 200910043R
- Conditions
- Cervical Cancer, Cancer
- Keywords
- Pap smear screening
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 6,000,000 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- Department of Health, Executive Yuan, R.O.C. (Taiwan)
- Study start
- Nov 2009
- First posted
- 17 Nov 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.
To investigate the protective effect of cervical cancer incidence and mortality by screening attending frequency or screening pattern, and to evaluate the possible risk of developing malignancies among women with cervical lesions, inflammation or infection.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Entire Taiwan women | – | – |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The entire Taiwan women with their information obtained from several national registries.
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 17 Nov 2009.
- Derived from this study: PubMed 21054764Cheng WF, Chen YL, You SL, Chen CJ, Chen YC, Hsieh CY, Chen CA. Risk of gynaecological malignancies in cytologically atypical glandular cells: follow-up study of a nationwide screening population. BJOG. 2011 Jan;118(1):34-41. doi: 10.1111/j.1471-0528.2010.02769.x. Epub 2010 Nov 4.
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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.
Chi-An Chen, MD principal investigator
National Taiwan University Hospital
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 and Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 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 Taiwan. 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 Yun-Yuan Chen, PhD (+886 2 23910409 ext. 23, b87801006@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01015079, 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 17 Nov 2009.