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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cervical Cancer

Intervention / Treatment
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* Other: Conservative management


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Conservative management<br>Patients diagnosed of CIN-II by directed biopsy | Other: Conservative management<br>* Control of CIN-II with cytology and colposcopy to try to avoid unnecessary surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Status of cervix pathology using cervical smear test (CIN grade) | 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. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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expectant management, p16, immunohistochemistry, regression, progression, cervical intraepithelial neoplasia