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

P

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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