Trial of CINtec in comparison with cervical cytology in screening for precursors of cancer of the cervix

Cervical cytology screening programs are effective in reducing the incidence and mortality from the disease. Although some benefit in reduction in mortality probably arises from the early detection of invasive cancer, reduction in incidence is due to the detection and treatment of obligate precursors of invasive cancer, especially those classified histologically as carcinoma in situ or severe dysplasia. It is unclear what contribution to this reduction in incidence is derived from the earlier detection of moderate dysplasia, as the majority of these lesions regress spontaneously, while those that progressed to CIN 3 can be readily detected and treated at that stage. However, it now seems clear that little benefit derives from the treatment of the large numbers of mild dysplasias that can be detected, especially in young women. Recently, a test specific for evidence of infection with oncogenic types of HPV has been marketed, and it has increasingly been evaluated for screening. A major difficulty with this test is that it has no ability to discriminate between transitory infections and those that are likely to be persistent, only the latter likely to be relevant to the occurrence of the cervical cancer.

What is now required to overcome the disadvantages of both conventional cervical cytology and the Hybrid Capture 2-test is a test that indicates that an oncogenic HPV virus has already been integrated into the genome of the relevant cells of the host. It is believed that a new test that can be applied to both standard pap-smears and Thin PrepÔ specimens which may have these desirable characteristics is CINtec. This test identifies a protein marker of persistent HPV infection, that studies to date suggest is not expressed in normal epithelium, normal proliferating cells, inflammatory lesions, metaplastic lesion and low-grade CIN lesions not infected with high risk HPV. A study protocol has been developed to compare this new test with standard pap-smear cervical cytology.

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