Cervical CancerNCT00201370
A Multi-center Survey of HPV in Cervical Intraepithelial Neoplasia (CIN) With Longitudinal Follow-up of LSIL Cases
An observational study of Cervical Cancer and Low-grade Squamous Intraepithelial Lesion,, run by National Health Research Institutes, Taiwan at 4 sites in Taiwan.
Trial summary
The aims of this study are: 1. Surveillance of the prevalence of HPV infection in ASCUS, AGCUS and SIL cases pooled from medical centers in Taiwan and analysis of the related epidemiological factors. 2. Read more about this study
- Who is it for?
- Ages 20 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer, Low-grade Squamous Intraepithelial Lesion,, Human Papillomavirus
- How many people
- 1,000 participants
- Where
- 4 sitesTaiwan
- Study dates
- Aug 1999to Mar 2004
- 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 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women were invited to participate in the cross-sectional study
Who may be able to join
- Women visiting the gynecologic clinic of the participating medical centers and have a recent (within three months) Pap smear result of ASCUS, AGCUS, LSIL and HSIL of during the study period will be invited to this study.
- An informed consent signed.
Who cannot join
- Women who are not pregnant, had had no previous CIN
Trial locations and contacts
4 sites in 1 country.
Taiwan4 sites
Kaohsiung Medical University Hospital
Kaohsiung City, 80708
Tri-Services General Hospital
Taipei, 11490
National Taiwan University Hospital
Taipei, 115
Chang-Gung Memorial Hospital(Lin-Kou),
Taoyuan, 333
About this study
The aims of this study are:
- Surveillance of the prevalence of HPV infection in ASCUS, AGCUS and SIL cases pooled from medical centers in Taiwan and analysis of the related epidemiological factors.
- Providing a better understanding of the natural history of HPV infection with its correlation with pathologic changes through a longitudinal follow-up of LSIL cases.
Read the detailed description
Carcinoma of the uterine cervix is by far the most prevalent cancer of women in Taiwan and worldwide. In 1994, it ranked the top of female cancer incidence with 3000 new cases annually and claimed nearly 1000 lives. The major cause of this malignant disease is now pointed to the infection of oncogenic types of human papillomavirus (HPV). HPV infection is sexually transmitted, affects the immature metaplastic cells of uterine cervix and, in an unknown proportion, results in squamous intraepithelial lesion (SIL) of differing severity. The natural history of HPV infection is by far elusive. It is not clear how the virus get into the cell, how the immune system respond to it, and how the epithelial cell get transformed. An average estimation holds that about 60% of low grade SIL will regress, 30% will persist, 10% will progress to high grade lesions and less than 1% become invasive lesions.
The aims of this study are:
- Surveillance of the prevalence of HPV infection in ASCUS, AGCUS and SIL cases pooled from medical centers in Taiwan and analysis of the related epidemiological factors.
- Providing a better understanding of the natural history of HPV infection with its correlation with pathologic changes through a longitudinal follow-up of LSIL cases.
Through a consensus of management of patients with abnormal Pap smear in TGOG, a standard protocol of specimen collection, clinical follow-up has been established. Patients with a Pap smear of ASCUS, AGCUS or SIL will be arranged with a repeat Pap smear and a colposcopy with or without biopsy. A cervical swab will be taken and sent to the core laboratory for HPV DNA detection and genotyping. Pap smear and biopsies were then panel-reviewed by Pathologists. Cytology-or pathology-proved LSIL cases will be followed every three months with Pap smear, colposcopy and HPV test until disease progression or two consecutive negative results of all the three data. One thousand cases fulfilling "aim 1" will be analyzed during the first year, and the nature course of about 300 LSIL cases will be followed at the end of the third year.
- Keywords
- cervical neoplasia;, human papillomavirus,, PCR,, risk factors,, Taiwan
- Medical subject headings
- Uterine Cervical Neoplasms, Squamous Intraepithelial Lesions
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is the disease-free survival.
Measured: 5
Secondary outcomes (1)
Secondary endpoints include overall survival and tumor response rate.
Measured: 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startAug 1999
- Primary completionFeb 2004
- Study completionMar 2004
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.
- 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
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Health Research Institutes, Taiwan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tang-Yuan Chu, M.D., Ph.D., Principal investigator, Taiwan cooperative oncology group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00201370
- Sponsor's protocol ID
- T1899
- Status last verified
- Sep 2005
- First submitted
- 14 Sep 2005
- Last updated
- 25 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Journal of Medical Virology Volume 77, Issue 2, pages 273-281, October 2005
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Survey of HPV in Cervical Intraepithelial Neoplasia (CIN) With Longitudinal Follow-up of LSIL Cases
- ClinicalTrials.gov ID
- NCT00201370
- Acronym / sponsor ID
- T1899
- Keywords
- cervical neoplasia;, human papillomavirus,, PCR,, risk factors,, Taiwan
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- National Health Research Institutes, TaiwanUniversity, hospital or other
- Study start
- Aug 1999
- Primary completion
- Feb 2004 (actual)
- Study completion
- Mar 2004 (actual)
- First posted
- 20 Sep 2005 (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 aims of this study are:
- Surveillance of the prevalence of HPV infection in ASCUS, AGCUS and SIL cases pooled from medical centers in Taiwan and analysis of the related epidemiological factors.
- Providing a better understanding of the natural history of HPV infection with its correlation with pathologic changes through a longitudinal follow-up of LSIL cases.
Detailed description
Carcinoma of the uterine cervix is by far the most prevalent cancer of women in Taiwan and worldwide. In 1994, it ranked the top of female cancer incidence with 3000 new cases annually and claimed nearly 1000 lives. The major cause of this malignant disease is now pointed to the infection of oncogenic types of human papillomavirus (HPV). HPV infection is sexually transmitted, affects the immature metaplastic cells of uterine cervix and, in an unknown proportion, results in squamous intraepithelial lesion (SIL) of differing severity. The natural history of HPV infection is by far elusive. It is not clear how the virus get into the cell, how the immune system respond to it, and how the epithelial cell get transformed. An average estimation holds that about 60% of low grade SIL will regress, 30% will persist, 10% will progress to high grade lesions and less than 1% become invasive lesions.
The aims of this study are:
- Surveillance of the prevalence of HPV infection in ASCUS, AGCUS and SIL cases pooled from medical centers in Taiwan and analysis of the related epidemiological factors.
- Providing a better understanding of the natural history of HPV infection with its correlation with pathologic changes through a longitudinal follow-up of LSIL cases.
Through a consensus of management of patients with abnormal Pap smear in TGOG, a standard protocol of specimen collection, clinical follow-up has been established. Patients with a Pap smear of ASCUS, AGCUS or SIL will be arranged with a repeat Pap smear and a colposcopy with or without biopsy. A cervical swab will be taken and sent to the core laboratory for HPV DNA detection and genotyping. Pap smear and biopsies were then panel-reviewed by Pathologists. Cytology-or pathology-proved LSIL cases will be followed every three months with Pap smear, colposcopy and HPV test until disease progression or two consecutive negative results of all the three data. One thousand cases fulfilling "aim 1" will be analyzed during the first year, and the nature course of about 300 LSIL cases will be followed at the end of the third year.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women were invited to participate in the cross-sectional study
Key inclusion criteria (2 listed)
- Women visiting the gynecologic clinic of the participating medical centers and have a recent (within three months) Pap smear result of ASCUS, AGCUS, LSIL and HSIL of during the study period will be invited to this study.
- An informed consent signed.
Key exclusion criteria (1 listed)
- Women who are not pregnant, had had no previous CIN
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 primary endpoint is the disease-free survival.
Time frame: 5
1 secondary outcome
Secondary endpoints include overall survival and tumor response rate.
Time frame: 5
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 25 Mar 2016.
- Results publicationJournal of Medical Virology Volume 77, Issue 2, pages 273-281, October 2005
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Tang-Yuan Chu, M.D., Ph.D. principal investigator
Taiwan cooperative oncology group
4 sites 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 Low-grade Squamous Intraepithelial Lesion,, run by National Health Research Institutes, Taiwan at 4 sites 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 2 inclusion and 1 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 25 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
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 primary endpoint is the disease-free survival. (time frame: 5). 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 NCT00201370, 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 25 Mar 2016.