Cervical Cancer ScreeningPhase 2NCT04650711
Immunohistochemical Staining of p16 for the Screening of Cervical Cancer
A Phase 2 study testing p16 protein expression in people with Cervical Cancer Screening and p16 Protein, run by Lei Li at 1 site in China.
Trial summary
Cyclin kinase inhibitor P16INK4A has overexpression in cervical cancer, and hence becoming an alternative method for cervical cancer screening. This study is to investigate the clinical value of P16INK4A and high-risk human papillomavirus (hrHPV) detection of cervical intraepithelial neoplasia (CIN) 2 or more severe… Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Cervical Cancer Screening, p16 Protein, Cytology
- What is being tested?
- p16 protein expression
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteChina
- Study dates
- 26 Nov 2020to 26 Nov 2020
- Phase
- Phase 2
- 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 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or older
- Signed an approved informed consents
- With sufficient cytology sample for p16 testing
- With definite results of cytology and/or high-risk human papillomavirus and cervical histology
Who cannot join
- Not meeting all of the inclusion criteria
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Lei Li
Beijing, Beijing Municipality, 100730
Lei Li, MD, 8613911988831, lileigh@163.com
About this study
Cyclin kinase inhibitor P16INK4A has overexpression in cervical cancer, and hence becoming an alternative method for cervical cancer screening. This study is to investigate the clinical value of P16INK4A and high-risk human papillomavirus (hrHPV) detection of cervical intraepithelial neoplasia (CIN) 2 or more severe lesions (CIN2+). All eligible participants accept P16INK4A testing, with cytology and/or hrHPV assay. P16INK4A immunohistochemical staining is performed on the retained specimens of cytology. The primary endpoint is the diagnostic accuracy of P16INK4A compared with cytology and/or hrHPV status based on histology results. The accuracy analysis includes sensitivity, specificity, negative predictive value and positive predictive value.
- Conditions
- Cervical Cancer Screening, p16 Protein, Cytology, High-risk Human Papillomavirus, Diagnostic Accuracy, Histology
- Being tested
- p16 protein expression
- Medical subject headings
- Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
p16 protein expressionDiagnostic test
Also called p16INK4A immunohistochemical staining
P16INK4A immunohistochemical staining is to be performed in residual cytology samples.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | All eligible participants as one group accept P16INK4A testing, with cytology and/or hrHPV assay. Receives: Diagnostic Test: p16 protein expression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of p16 protein expression
Diagnostic accuracy of p16 protein expression for detecting cervical intraepithelial neoplasia (CIN) 2 or more severe lesions (CIN2+)
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study start26 Nov 2020
- Primary completion26 Nov 2020 (estimated)
- Study completion26 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Cancer ScreeningStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- All eligible participants as a cohort, accept P16INK4A testing, with cytology and/or hrHPV assay
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lei Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lei Li, Peking Union Medical College Hospital
- Investigators
- Lei Li, M.D., Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04650711
- Sponsor's protocol ID
- CC-P16
- Status last verified
- Nov 2020
- First submitted
- 25 Nov 2020
- Last updated
- 3 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunohistochemical Staining of p16 for the Screening of Cervical Cancer
- ClinicalTrials.gov ID
- NCT04650711
- Acronym / sponsor ID
- CC-P16
- Conditions
- Cervical Cancer Screening, p16 Protein, Cytology, High-risk Human Papillomavirus, Diagnostic Accuracy, Histology
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Lei LiUniversity, hospital or other
- Study start
- 26 Nov 2020 (actual)
- Primary completion
- 26 Nov 2020 (estimated)
- Study completion
- 26 Nov 2020 (estimated)
- First posted
- 3 Dec 2020 (actual)
- 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.
Cyclin kinase inhibitor P16INK4A has overexpression in cervical cancer, and hence becoming an alternative method for cervical cancer screening. This study is to investigate the clinical value of P16INK4A and high-risk human papillomavirus (hrHPV) detection of cervical intraepithelial neoplasia (CIN) 2 or more severe lesions (CIN2+). All eligible participants accept P16INK4A testing, with cytology and/or hrHPV assay. P16INK4A immunohistochemical staining is performed on the retained specimens of cytology. The primary endpoint is the diagnostic accuracy of P16INK4A compared with cytology and/or hrHPV status based on histology results. The accuracy analysis includes sensitivity, specificity, negative predictive value and positive predictive value.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All eligible participants as a cohort, accept P16INK4A testing, with cytology and/or hrHPV assay
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Diagnostic Test: p16 protein expressionAll eligible participants as one group accept P16INK4A testing, with cytology and/or hrHPV assay. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18 years or older
- Signed an approved informed consents
- With sufficient cytology sample for p16 testing
- With definite results of cytology and/or high-risk human papillomavirus and cervical histology
Key exclusion criteria (1 listed)
- Not meeting all of the inclusion criteria
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 |
|---|---|---|
| p16 protein expressionAlso: p16INK4A immunohistochemical stainingP16INK4A immunohistochemical staining is to be performed in residual cytology samples. | Diagnostic test | Study group |
Primary outcome
Diagnostic accuracy of p16 protein expression
Time frame: Two years
Diagnostic accuracy of p16 protein expression for detecting cervical intraepithelial neoplasia (CIN) 2 or more severe lesions (CIN2+)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2020.
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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.
Lei Li, M.D. principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing p16 protein expression in people with Cervical Cancer Screening and p16 Protein, run by Lei Li 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 4 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: status not confirmed, as of the sponsor's last update on 3 Dec 2020. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Lei Li, M.D. (+8613911988831, lileigh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of p16 protein expression (time frame: Two years). 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 3 Dec 2020.