The current standard of care for detecting and treating cervical cancer and precancer involves the use of Papanicolaou smears, and if this is positive it is followed by colposcopically directed biopsy, with treatment if the biopsy is positive. Several highly trained medical personnel are required for this sequence of procedures and the patient may need to make as many as three visits to various clinics. Furthermore, the results of Papanicolaou smears and biopsies are based on subjective evaluation by human pathologists. This approach to detecting and treating cervical cancer and pre-cancer is not feasible for the developing world where there is a shortage of pathologists and infrastructure. We are investigating devices based on optical technologies that could save many lives in the developing world, and could provide more cost-effective and accurate methods for screening and diagnosis of cervical neoplasia in the developed world. Several technologies are proposed for investigation in this Program Project, including point probes for fluorescence and reflectance spectroscopy (which have already been built and tested), quantitative pathology including cytopathology (examination of cells from a Papanicolaou smear) and histopathology (examination of tissue slices from a biopsy), the Multispectral Digital Colposcope (MDC;a device for imaging the cervix in a small number of reflectance and fluorescence bandwidths), a combined point-probe/MDC, an in vivo confocal microscope, a low-cost, battery powered device for use in low-resource settings (the DIA, or Diagnostic Imgaing Aid), and contrast agents to aid visualization. The Biostatistics and Data Management Core interacts with and is vital to all other Cores and Projects. The technologies that are at the heart of this proposal produce large quantifies of data in addition to more standard types of data on patients such as biographical data (e.g. age, number of children, etc.) and medical data (e.g., results from pathology readings). Numerous challenges are presented by the collection, processing, quality assurance, maintenance, and analysis of these data. The Core maintains the database in which all research data obtained under the grant is stored. The management of this database includes ensuring data security and integrity and preserving patient privacy.
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