Cervical CancerCOCYNCT01058460
HPV-cytology Testing Versus Cytology Testing for the Detection of High Grade CIN
A study testing HPV-cytology co-testing in people with Cervical Cancer and Cervical Intraepithelial Neoplasia, run by The University of Hong Kong at 1 site in China.
Trial summary
To compare the effects of conventional cytology testing with concommitant HPV-cytology testing for the detection of high grade cervical lesions in primary cervical cancer screening in Hong Kong Hypotheses: 1. Read more about this study
- Who is it for?
- Ages 30 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer, Cervical Intraepithelial Neoplasia
- What is being tested?
- HPV-cytology co-testing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12,000 participants
- Where
- 1 siteChina
- Study dates
- Jun 2010to Jun 2017
- Phase
- Interventional
- 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 30 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ethnic Chinese women aged 30 to 60 years who have completed a written consent
- Women who have not attended screening for the past 3 years or more will be given priority
Who cannot join
- Currently pregnant
- Without a cervix
- Congenital abnormalities of the lower genital tract
- Previous history of invasive cervical cancer
- Who has been followed-up or treated for an abnormal cytology result in the past 12 months
- Who are unable to provide consent
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Obstetrics & Gynaecology, The University of Hong Kong
Hong Kong SAR
Hextan YS Ngan, MD, MBBS
About this study
Official title: A Randomized Controlled Trial Comparing Concomitant HPV-cytology Testing With Conventional Cytology Testing for the Detection of High Grade Cervical Intraepithelial Neoplasia in Primary Cervical Cancer Screening in Hong Kong
To compare the effects of conventional cytology testing with concommitant HPV-cytology testing for the detection of high grade cervical lesions in primary cervical cancer screening in Hong Kong
Hypotheses:
- There is a significant difference in the number of CIN2+ cases detected between the cytology testing group and the cytology-HPV co-testing group at baseline.
- Significantly more CIN2+ cases will be detected at the second round of screening among participants with normal cytology result in the control arm than those with normal cytology and negative HPV results in the intervention arm.
- Being tested
- HPV-cytology co-testing
- Keywords
- Cervical Intraepithelial Neoplasia, Grade III, Cervical Intraepithelial Neoplasia, Grade II
- Medical subject headings
- Uterine Cervical Neoplasms, Uterine Cervical Dysplasia, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPV-cytology co-testingProcedure or surgery
Subjects will receive HPV testing and conventional cytology testing at baseline. Follow up management will be based on both results.
| Study group | Role | What they receive |
|---|---|---|
| cytology | No intervention | Subjects in the control arm will receive conventional cytology testing and HPV testing at baseline. Follow up management will be based on the cytology result according to current practice. |
| HPV-cytology | Experimental | Subjects in the HPV-cytology arm will receive HPV testing and cytology testing at baseline. Follow up management will be based on both results. Receives: Procedure: HPV-cytology co-testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histological CIN2, CIN3 and cervical carcinoma
Measured: At baseline and each subsequent follow-up
Secondary outcomes (1)
Clearance of mild cervical abnormalities among HPV negative subjects
Measured: At baseline and 1-year after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2010 (estimated)
- Study startJun 2010
- Primary completionJun 2017 (estimated)
- Study completionJun 2017 (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.
- More trials run by The University of Hong KongThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- The Family Planning Association of Hong Kong
- Investigators
- Hextan YS Ngan, MD, MBBS, Principal investigator, Department of Obstetrics & Gynaecology, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01058460
- Sponsor's protocol ID
- UW09-377
- Acronym
- COCY
- Status last verified
- May 2011
- First submitted
- 27 Jan 2010
- Last updated
- 1 Jun 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Concomitant HPV-cytology Testing With Conventional Cytology Testing for the Detection of High Grade Cervical Intraepithelial Neoplasia in Primary Cervical Cancer Screening in Hong Kong
- ClinicalTrials.gov ID
- NCT01058460
- Acronym / sponsor ID
- COCY / UW09-377
- Keywords
- Cervical Intraepithelial Neoplasia, Grade III, Cervical Intraepithelial Neoplasia, Grade II
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12,000 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- The Family Planning Association of Hong Kong
- Study start
- Jun 2010
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 28 Jan 2010 (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 compare the effects of conventional cytology testing with concommitant HPV-cytology testing for the detection of high grade cervical lesions in primary cervical cancer screening in Hong Kong
Hypotheses:
- There is a significant difference in the number of CIN2+ cases detected between the cytology testing group and the cytology-HPV co-testing group at baseline.
- Significantly more CIN2+ cases will be detected at the second round of screening among participants with normal cytology result in the control arm than those with normal cytology and negative HPV results in the intervention arm.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cytology | No intervention | –Subjects in the control arm will receive conventional cytology testing and HPV testing at baseline. Follow up management will be based on the cytology result according to current practice. |
| HPV-cytology | Experimental | Procedure: HPV-cytology co-testingSubjects in the HPV-cytology arm will receive HPV testing and cytology testing at baseline. Follow up management will be based on both results. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Ethnic Chinese women aged 30 to 60 years who have completed a written consent
- Women who have not attended screening for the past 3 years or more will be given priority
Key exclusion criteria (6 listed)
- Currently pregnant
- Without a cervix
- Congenital abnormalities of the lower genital tract
- Previous history of invasive cervical cancer
- Who has been followed-up or treated for an abnormal cytology result in the past 12 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HPV-cytology co-testingSubjects will receive HPV testing and conventional cytology testing at baseline. Follow up management will be based on both results. | Procedure or surgery | HPV-cytology |
Primary outcome
Histological CIN2, CIN3 and cervical carcinoma
Time frame: At baseline and each subsequent follow-up
1 secondary outcome
Clearance of mild cervical abnormalities among HPV negative subjects
Time frame: At baseline and 1-year after
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2011.
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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.
Hextan YS Ngan, MD, MBBS principal investigator
Department of Obstetrics & Gynaecology, The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HPV-cytology co-testing in people with Cervical Cancer and Cervical Intraepithelial Neoplasia, run by The University of Hong Kong 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 2 inclusion and 6 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 1 Jun 2011. 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 Hextan YS Ngan, MD, MBBS (852-2255-4684, hysngan@hkusua.hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Histological CIN2, CIN3 and cervical carcinoma (time frame: At baseline and each subsequent follow-up). It is what the study was designed to measure, not a finding.
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 1 Jun 2011.