p16 and Ki-67 Stainings and Natural Killer (NK) Cells in CIN-II Management

Predictive Value of p16 and Ki-67 Immunohistochemical Staining and NK Cells in Expectant Management of Cervical Intraepithelial Neoplasia Grade 2

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02522585

Enrollment

100

Registered

2015-08-13

Start date

2011-12-31

Completion date

2015-12-31

Last updated

2016-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Cancer

Keywords

expectant management, p16, immunohistochemistry, regression, progression, cervical intraepithelial neoplasia

Brief summary

The objective of this study is to evaluate the outcome of cervical intraepithelial neoplasia grade 2 (CIN-II) patients followed up without treatment for 24 months according to p16 and ki-67 immunohistochemical staining and to the expression of NK cell receptors.

Detailed description

Cervical cancer and its precursor lesions, cervical intraepithelial neoplasia (CIN), represents a significant public health problem,induced by persistent infection of human papillomavirus (HPV). It is known that a significant percentage of CIN regresses spontaneously and only a minority of these lesions progress to cervical cancer. CIN-II is an intermediate state that can regress to CIN-I or less, or progress to CIN-III spontaneously. The rate of spontaneous regression and progression in follow-up studies are around 40-60% and 10-20%, respectively. Overestimating CIN-II lesions may cause overtreatment by excisional treatment and increase the risk of subsequent obstetric complications. Patients newly diagnosed with CIN-II colposcopy-directed biopsy who agreed to follow up at four months intervals for at least 12 months with cervical cytology and colposcopy, were prospectively recruited. p16, ki-67 and NK receptors expression were analyzed in all CIN-II biopsies. Total regression, partial regression, persistence and progression rates of CIN-II were defined as a final outcome.

Interventions

OTHERConservative management

Control of CIN-II with cytology and colposcopy to try to avoid unnecessary surgery

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* preferred expectant management than immediate treatment * exocervical histological diagnosis of CIN-II * lesion completely visualized by colposcopy * entire squamocolumnar junction of the cervix was visible * showing no evidence of any immunodeficiency disease * no history of previous cervical treatment * could be followed-up every four months during one year * signed consent form

Exclusion criteria

* not coming to follow up appointments

Design outcomes

Primary

Measure	Time frame	Description
Status of cervix pathology using cervical smear test (CIN grade)	2 years	Cervical cytology test and colposcopy every 4 months starting with diagnose CIN-II or CIN-III means presence of lesion, CIN-I is regression of the lesion, and Negative is abscence of lesion.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026