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

Cervical Cancer Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02522585
Study type Observational
Source Parc de Salut Mar
Contact
Status Completed
Phase N/A
Start date December 2011
Completion date December 2015
View Details
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