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

Parc de Salut Mar

Status: Completed

Conditions: Cervical Cancer

Treatments: Other: Conservative management

Study type: Observational

Funder types: Other

Identifiers

NCT02522585

CIN-II p16 NK

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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

Trial design

100 participants in 1 patient group

Conservative management

Description:

Patients diagnosed of CIN-II by directed biopsy

Treatment:

Other: Conservative management