Immunohistochemical Staining of p16 for the Screening of Cervical Cancer

NCT04650711 | Unknown Phase 2

• 1 other identifier: CC-P16
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy of p16 protein expression

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

  Two years

Study Arms (1)

Study group

EXPERIMENTAL

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

Diagnostic Test: p16 protein expression

Interventions

p16 protein expression DIAGNOSTIC_TEST

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

Also known as: p16INK4A immunohistochemical staining

Study group

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Lei Li: lead

Study Sites (1)

Lei Li

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Dysplasia

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Lei Li, M.D.

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lei Li, M.D.

CONTACT

+8613911988831; lileigh@163.com

Ming Wu, M.D.

CONTACT

+8613801224549; wuming@pumch.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: All eligible participants as a cohort, accept P16INK4A testing, with cytology and/or hrHPV assay

Study Record Dates

• First Submitted: November 25, 2020
• First Posted: December 3, 2020
• Study Start: November 26, 2020
• Primary Completion: November 26, 2020
• Study Completion: November 26, 2020
• Last Updated: December 3, 2020

Record last verified: 2020-11

Locations

CN (1)