Cervical cancer is the second leading cause of death for women worldwide; 85% of deaths occur in low and middle- income countries (LMICs), despite the fact that well-established interventions exist for pre-invasive disease. In the U.S., screening for cervical cancer is performed with the Papanicolaou (Pap) smear. Colposcopy, which visualizes the acetic acid stained cervix with a low power microscope, followed by biopsy of cervical abnormalities, serves as a confirmatory test for women with positive screening results. Women with pre-cancer are treated via excision of a portion of the cervix using Loop Electrosurgical Excision Procedure (LEEP). Women with cancer are referred to a combination of local and/or systemic therapy depending on the stage of invasive disease. This model is not practical to implement in medically-underserved regions due to lack of resources to procure, implement, and maintain the technologies in the care cascade. Thus, alternative protocols that employ low-cost, simple-to-use technologies are needed to mitigate cervical cancer. Our vision is to develop high quality, low-cost interventions that will be effective in low-resource health facilities to address shortcomings of current technological solutions to cervical cancer prevention. This vision requires 3 distinct innovations: 1) an ultra-portable visualization device coupled with routinely used contrast agents to reduce discomfort, enable visualization of microscopic disease, and provide quality control through image review and archiving (Aim 1); 2) enhanced contrast and smart algorithms to reduce unnecessary referrals or treatment of screen positive women (in the absence of confirmatory biopsy) (Aim 2); and 3) a low-cost therapeutic that is as effective as current ablative approaches but more readily accessible to treat pre-invasive disease (Aim 3). These innovations build upon: 1) a novel Pocket colposcope developed under previous funding that enables portable colposcopy of the cervix; and 2) preliminary results that support these new innovations.
The goal of this R01 is for PIs, Ramanujam, Sapiro and Katz to work in partnership to develop a technological strategy to transform the screening, diagnosis, and treatment paradigm for cervical cancer prevention in low-resource communities. The proposed research is significantly relevant to public health due to the potential to contribute to the improvement of cervical cancer prevention, and thus the reduction in mortality rate of this imminently preventable disease.