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

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

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-12-31

Study Completion Date

2015-12-31

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.

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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.

Conditions

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Cervical Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Conservative management

Patients diagnosed of CIN-II by directed biopsy

Conservative management

Intervention Type OTHER

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

Interventions

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Conservative management

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

Intervention Type OTHER

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