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Immunohistochemical Staining of p16 for the Screening of Cervical Cancer

NCT ID: NCT04650711

Last Updated: 2020-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-26

Study Completion Date

2020-11-26

Brief Summary

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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.

Detailed Description

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Conditions

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Cervical Cancer Screening p16 Protein Cytology High-risk Human Papillomavirus Diagnostic Accuracy Histology Cervical Intraepithelial Neoplasia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

All eligible participants as a cohort, accept P16INK4A testing, with cytology and/or hrHPV assay
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Study group

All eligible participants as one group accept P16INK4A testing, with cytology and/or hrHPV assay.

Group Type EXPERIMENTAL

p16 protein expression

Intervention Type DIAGNOSTIC_TEST

P16INK4A immunohistochemical staining is to be performed in residual cytology samples.

Interventions

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p16 protein expression

P16INK4A immunohistochemical staining is to be performed in residual cytology samples.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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p16INK4A immunohistochemical staining

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Lei Li

OTHER

Sponsor Role lead

Responsible Party

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Lei Li

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Lei Li, M.D.

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Locations

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Lei Li

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Lei Li, M.D.

Role: CONTACT

Phone: +8613911988831

Email: [email protected]

Ming Wu, M.D.

Role: CONTACT

Phone: +8613801224549

Email: [email protected]

Facility Contacts

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Lei Li, MD

Role: primary

Other Identifiers

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CC-P16

Identifier Type: -

Identifier Source: org_study_id