A Novel Microscope for the Diagnosis of Pre-Cancerous or Suspicious Lesions in Women with Positive Cervical Cancer Screening
This clinical trial test how well a novel microscope, called deep depth-of-field (DeepDOF), works in diagnosing pre-cancerous or suspicious lesions in women with positive cervical cancer screening. Cervical cancer is the most commonly diagnosed cancer and leading cause of cancer death among women in many low- and middle-income countries (LMICs), particularly among women living with HIV (WLWH). Cervical cancer screening programs are being widely implemented in many LMICs and some screen-positive women need further diagnostic evaluation. These women may require cervical biopsy and/or a loop electrosurgical excision procedure (LEEP) for tissue examination. A standard microscope tissue examination, called histopathology, is then completed to diagnose if cancer is present. However, for women in LMICs, a standard histopathologic diagnosis is rarely obtained or is so delayed that it is of limited value due to the costs associated with histopathology, a lack of appropriate staff, as well as shortages of costly tissue processing equipment. There is a well-recognized and crucial gap to strengthen histopathology services in LMICs. These delays are especially significant for WLWH, who have a 6-time increased risk of developing cervical cancer. To help reduce the cost and technical complexity of laboratory histopathology, a DeepDOF microscope was developed. DeepDOF can be used to quickly image large areas of tissue to provide histologic quality images in real time. Using DeepDOF may be effective in diagnosis of pre-cancerous or suspicious lesions in women with positive cervical cancer screening.