Fluorescence and reflectance spectroscopic imaging scan for detection of cervical neoplasia

Invasive cervical cancer is preceded by a state of cervical intraepithelial
neoplasia (CIN). Cervical cancer screening is known to decrease cancer
incidence by early detection and treatment of high grade CIN lesions. Limited
sensitivity and specificity of different screening- and triage-options, result
in missed lesions or overtreatment. Previous studies have shown that a cervical
scan based on fluorescence and reflectance spectroscopy is a potential method
for triaging women at risk for moderate and high grade dysplasia. Fluorescence
and reflectance spectroscopy has been successfully evaluated in a small number
of clinical trials for detecting neoplasia of the cervix. Before it can be used
as an integrated triage test, validation of previously published results is
essential.

To determine sensitivity, specificity, positive predictive value and negative
predictive value of the spectroscopic cervical imaging device in detection of
high grade cervical intraepithelial neoplasia.

Prospective multi-centre cohort study

Patients will undergo a, one minute, spectroscopic cervical vaginal scan,
performed by a healthcare worker in the outpatient clinic. Also an additional
hrHPV test with genotyping will be performed on a cervical smear. In most cases
a cervical smear will be taken for standard examination. When this is not the
case, an additional smear will be taken for the hrHPV test.

Patients that undergo regular colposcopic evaluation or a control pap-smear
will undergo an additional multimodal spectroscopy cervical scan. This scan had
previously been described to be without serious adverse events and well
accepted by women. No tissue samples are taken during the scan, no additional
hospital visits or questionnaires are needed. When no cervical smear is taken
during regular diagnostics, an additional smear is taken for the study hrHPV
test. The burden/risk of this additional smear is small.