An observational study in Cervical Cancer, sponsored by Parc de Salut Mar. Completed. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-04-20.
Sponsored by Parc de Salut Mar · Observational
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.
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.
356 studies on the registry are indexed under Uterine Cervical Dysplasia; 68 are open to participants now.
This study's enrollment of 100 is below the median of 470 across 96 observational studies indexed under Uterine Cervical Dysplasia.
Browse Uterine Cervical Dysplasia studies →Parc de Salut Mar is the lead sponsor of 180 studies on the registry; 27 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult females with CIN-II lesion on cervical biopsy that agree to a conservative management during a period not more than 24 months, referred to the low genital tract diseases clinic of Hospital del Mar.
Exclusion Criteria:
Patients diagnosed of CIN-II by directed biopsy
Other: Conservative management
Control of CIN-II with cytology and colposcopy to try to avoid unnecessary surgery
Status of cervix pathology using cervical smear test (CIN grade)
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.
Time frame: 2 years
No study locations are listed for this record.
This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
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Parc de Salut Mar