CancerNCT02063152
102 Annual Pap Smear Screening Database Maintenance Project
An observational study of Cancer and Human Papillomavirus, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
This study aimed to evaluate the subsequent cancer risks, including gynecological cancers and malignancies at other sites, after the detection of screening positives and the diagnosis for primary cervical cancer. Read more about this study
- Who is it for?
- Ages 20 to 130 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cancer, Human Papillomavirus
- How many people
- 300,000 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 1995to Dec 2020
- How long will I take part?
- 25 Years
- 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 130 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women attended screening and found abnormal results, and women who were diagnosed as cervical cancer were the main study population. Women who did not attend screening for at least 6 years were also included.
Who may be able to join
- Citizens in Taiwan
- Women who attended screening, or who were diagnosed as cervical cancer
- Women who did not attend screening for at least 6 years
Who cannot join
- Women died before the follow-up initiation
- Women who had received hysterectomy before the follow-up initiation
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taiwan Cervical Cancer Prevention Monitoring Center
Taipei, 10055
Hui-Chi Chen, PhD, +886 2 23910409 ext. 20, d90842001@ntu.edu.tw
Chi-An Chen, MD
About this study
This study aimed to evaluate the subsequent cancer risks, including gynecological cancers and malignancies at other sites, after the detection of screening positives and the diagnosis for primary cervical cancer.
- Conditions
- Cancer, Human Papillomavirus
- Medical subject headings
- 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to the cancer diagnosis or the recurrence, the death, or the last date of follow-up, whichever came first
Measured: up to 25 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2014 (estimated)
- Study startJan 1995
- Primary completionDec 2020 (estimated)
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 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
- Prospective
- Enrolment
- 300,000 participants (estimated)
- Target duration
- 25 Years
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chi-An Chen, MD, Principal investigator, Department of Obstetrics and Gynecology, College of Medicine, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02063152
- Sponsor's protocol ID
- 201305072RINC
- Status last verified
- Aug 2017
- First submitted
- 10 Feb 2014
- Last updated
- 17 Aug 2017
- Results posted
- No
Publications
Tai YJ, Chen YY, Hsu HC, Chiang CJ, You SL, Chen CA, Cheng WF; Taiwan Cervical Cancer Control Task Force. Risks of cervical intraepithelial neoplasia grade 3 or invasive cancers in ASCUS women with different management: a population-based cohort study. J Gynecol Oncol. 2018 Jul;29(4):e55. doi: 10.3802/jgo.2018.29.e55. Epub 2018 Mar 20.
PubMed 29770625
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 102 Annual Pap Smear Screening Database Maintenance Project
- ClinicalTrials.gov ID
- NCT02063152
- Acronym / sponsor ID
- 201305072RINC
- Conditions
- Cancer, Human Papillomavirus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300,000 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jan 1995
- Primary completion
- Dec 2020 (estimated)
- First posted
- 14 Feb 2014 (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.
This study aimed to evaluate the subsequent cancer risks, including gynecological cancers and malignancies at other sites, after the detection of screening positives and the diagnosis for primary cervical cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 25 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Entire Taiwan women | – | – |
Who may qualify
- Ages
- 20 to 130 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women attended screening and found abnormal results, and women who were diagnosed as cervical cancer were the main study population. Women who did not attend screening for at least 6 years were also included.
Key inclusion criteria (3 listed)
- Citizens in Taiwan
- Women who attended screening, or who were diagnosed as cervical cancer
- Women who did not attend screening for at least 6 years
Key exclusion criteria (2 listed)
- Women died before the follow-up initiation
- Women who had received hysterectomy before the follow-up initiation
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
Time to the cancer diagnosis or the recurrence, the death, or the last date of follow-up, whichever came first
Time frame: up to 25 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2017.
- Derived from this study: PubMed 29770625Tai YJ, Chen YY, Hsu HC, Chiang CJ, You SL, Chen CA, Cheng WF; Taiwan Cervical Cancer Control Task Force. Risks of cervical intraepithelial neoplasia grade 3 or invasive cancers in ASCUS women with different management: a population-based cohort study. J Gynecol Oncol. 2018 Jul;29(4):e55. doi: 10.3802/jgo.2018.29.e55. Epub 2018 Mar 20.
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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
Department of Obstetrics and Gynecology, College of Medicine, National Taiwan 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 Cancer and Human Papillomavirus, 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.
Who may be eligible to take part?
The sponsor lists 3 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: status not confirmed, as of the sponsor's last update on 17 Aug 2017. 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 Hui-Chi Chen, PhD (+886 2 23910409 ext. 20, d90842001@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to the cancer diagnosis or the recurrence, the death, or the last date of follow-up, whichever came first (time frame: up to 25 years). 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 NCT02063152, 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 Aug 2017.