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

Completed

• Conditions: Cervical Cancer
• Interventions: Other: Conservative management

• Registration Number: NCT02522585
• Lead Sponsor: Parc de Salut Mar

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.

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2015-08-07
• Study First Submitted QC: 2015-08-11
• Study First Posted: 2015-08-13
• Primary Completion: 2015-11
• Study Completion: 2015-12
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-19
• Last Update Posted: 2016-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Conservative management	Conservative management	Patients diagnosed of CIN-II by directed biopsy

Primary Outcome Measures

Name	Time	Method
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.