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Immunohistochemical Staining of p16 for the Screening of Cervical Cancer

Primary Purpose

Cervical Cancer Screening, p16 Protein, Cytology

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
p16 protein expression
Sponsored by
Lei Li
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cervical Cancer Screening

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Exclusion Criteria:

  • Not meeting all of the inclusion criteria

Sites / Locations

  • Lei LiRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study group

Arm Description

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

Outcomes

Primary Outcome Measures

Diagnostic accuracy of p16 protein expression
Diagnostic accuracy of p16 protein expression for detecting cervical intraepithelial neoplasia (CIN) 2 or more severe lesions (CIN2+)

Secondary Outcome Measures

Full Information

First Posted
November 25, 2020
Last Updated
November 25, 2020
Sponsor
Lei Li
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1. Study Identification

Unique Protocol Identification Number
NCT04650711
Brief Title
Immunohistochemical Staining of p16 for the Screening of Cervical Cancer
Official Title
Immunohistochemical Staining of p16 for the Screening of Cervical Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 26, 2020 (Actual)
Primary Completion Date
November 26, 2020 (Anticipated)
Study Completion Date
November 26, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lei Li

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer Screening, p16 Protein, Cytology, High-risk Human Papillomavirus, Diagnostic Accuracy, Histology, Cervical Intraepithelial Neoplasia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
All eligible participants as a cohort, accept P16INK4A testing, with cytology and/or hrHPV assay
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study group
Arm Type
Experimental
Arm Description
All eligible participants as one group accept P16INK4A testing, with cytology and/or hrHPV assay.
Intervention Type
Diagnostic Test
Intervention Name(s)
p16 protein expression
Other Intervention Name(s)
p16INK4A immunohistochemical staining
Intervention Description
P16INK4A immunohistochemical staining is to be performed in residual cytology samples.
Primary Outcome Measure Information:
Title
Diagnostic accuracy of p16 protein expression
Description
Diagnostic accuracy of p16 protein expression for detecting cervical intraepithelial neoplasia (CIN) 2 or more severe lesions (CIN2+)
Time Frame
Two years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 Exclusion Criteria: Not meeting all of the inclusion criteria
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lei Li, M.D.
Phone
+8613911988831
Email
lileigh@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ming Wu, M.D.
Phone
+8613801224549
Email
wuming@pumch.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lei Li, M.D.
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lei Li
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lei Li, MD
Phone
8613911988831
Email
lileigh@163.com

12. IPD Sharing Statement

Learn more about this trial

Immunohistochemical Staining of p16 for the Screening of Cervical Cancer

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