Cervical CancerNCT02576158
HPV Integration Testing for Cervical Cancer Screening
An observational study of Cervical Cancer and Cervical Intraepithelial Neoplasia, run by Huazhong University of Science and Technology at 1 site in China.
Trial summary
The primary objective is to determine the sensitivity and specificity of the HPV Integration-based cervical screening for detection of high-grade cervical intraepithelial neoplasia (CIN), using colposcopic inspection as the reference method. Read more about this study
- Who is it for?
- Ages 30 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer, Cervical Intraepithelial Neoplasia
- What is being tested?
- TCT，HPV，colposcopic inspection
- Type of treatment
- Surgery or procedure
- How many people
- 12,000 participants
- Where
- 1 siteChina
- Study dates
- Apr 2015to Apr 2020
- 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 30 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: healthy women between the ages of 30 and 65 years
Who may be able to join
- Women aged 30-65 years old Attending the China population-based organised cervical screening program
Who cannot join
- Not providing informed consent
- previously confirmed CIN, cervical cancer, or other malignancies
- previous therapeutic procedure to cervix
- pregnancy
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Women's Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310006
Yuyan Mao, MD, 13989816955, maoyy3@yahoo.com.cn
About this study
Official title: HPV（Human Papillomavirus） Integration Testing for Cervical Cancer Screening
The primary objective is to determine the sensitivity and specificity of the HPV Integration-based cervical screening for detection of high-grade cervical intraepithelial neoplasia (CIN), using colposcopic inspection as the reference method. Lesions will be confirmed as malignant or CIN by colposcopic inspection and histopathologic examination.
- Being tested
- TCT，HPV，colposcopic inspection
- Medical subject headings
- Uterine Cervical Neoplasms, Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TCT，HPV，colposcopic inspectionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Subjects will be women, 30-65 years of age | Patients who are at average risk of developing cervical intraepithelial neoplasia or cervical cancer who are eligible for cervical cancer screening will be asked to collect Cervical Exfoliated Cells sample for the HPV integration screening test and for the HPV testing and TCT. Subjects with HPV positive will undergo colposcopy within 90 days of enrollment. Receives: Procedure: TCT，HPV，colposcopic inspection |
What is being measured
The primary outcome is the main question the study is designed to answer.
the sensitivity and specificity of the HPV Integration-based cervical screening for detection of high-grade cervical intraepithelial neoplasia (CIN)with comparison to HPV testing or TCT
Measured: 14 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2015 (estimated)
- Study startApr 2015
- Primary completionSep 2018 (estimated)
- Study completionApr 2020 (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 Huazhong University of Science and TechnologyThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 12,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ding Ma, Huazhong University of Science and Technology
- Investigators
- Ding Ma, MD, PhD, Study chair, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02576158
- Sponsor's protocol ID
- CCS-01
- Status last verified
- Jun 2017
- First submitted
- 22 Sep 2015
- Last updated
- 27 Jun 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HPV（Human Papillomavirus） Integration Testing for Cervical Cancer Screening
- ClinicalTrials.gov ID
- NCT02576158
- Acronym / sponsor ID
- CCS-01
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 12,000 participants (estimated)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 15 Oct 2015 (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 primary objective is to determine the sensitivity and specificity of the HPV Integration-based cervical screening for detection of high-grade cervical intraepithelial neoplasia (CIN), using colposcopic inspection as the reference method. Lesions will be confirmed as malignant or CIN by colposcopic inspection and histopathologic examination.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects will be women, 30-65 years of age | – | Procedure: TCT，HPV，colposcopic inspectionPatients who are at average risk of developing cervical intraepithelial neoplasia or cervical cancer who are eligible for cervical cancer screening will be asked to collect Cervical Exfoliated Cells sample for the HPV integration screening test and for the HPV testing and TCT. Subjects with HPV positive will undergo colposcopy within 90 days of enrollment. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- healthy women between the ages of 30 and 65 years
Key inclusion criteria (1 listed)
- Women aged 30-65 years old Attending the China population-based organised cervical screening program
Key exclusion criteria (4 listed)
- Not providing informed consent
- previously confirmed CIN, cervical cancer, or other malignancies
- previous therapeutic procedure to cervix
- pregnancy
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 |
|---|---|---|
| TCT，HPV，colposcopic inspection | Procedure or surgery | Subjects will be women, 30-65 years of age |
Primary outcome
the sensitivity and specificity of the HPV Integration-based cervical screening for detection of high-grade cervical intraepithelial neoplasia (CIN)with comparison to HPV testing or TCT
Time frame: 14 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2017.
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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.
Ding Ma, MD, PhD study chair
Huazhong University of Science and Technology
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 Cervical Intraepithelial Neoplasia, run by Huazhong University of Science and Technology 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 1 inclusion and 4 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 27 Jun 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 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 Danhui Weng, MD, PhD (+862783662681, weng.dh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the sensitivity and specificity of the HPV Integration-based cervical screening for detection of high-grade cervical intraepithelial neoplasia (CIN)with comparison to HPV testing or TCT (time frame: 14 Months). 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 27 Jun 2017.