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Monitoring Intrauterine Biomarkers to Detect Pre-Invasive Disease
There is currently no method to achieve early, accurate diagnosis, leading to widely disseminated, advanced stage disease in the majority of patients diagnosed. Conventionally, serum CA-125 measurements and ultrasonography have been used to detect ovarian carcinoma. However, these methods have been unsuccessful in identifying early disease or reducing the mortality of high grade serous carcinoma (HGSC). HGSC is also associated with mutations in the TP53 gene, leading to overexpression of mutant p53 proteins. We know that pre-cancerous lesions have been identified in the fallopian tubes of at-risk women; it is estimated that these lesions will take approximately 6.5 years to develop into carcinoma, leaving a tremendous window of opportunity. Therefore, diagnosis of precursor lesions will save lives and drastically reduce suffering by preventing invasive ovarian cancer. We hypothesize that transient, localized measurements of biomarkers in the vicinity of disease sites may improve the detection of low-volume disease. In the current funding cycle, we found that our implantable sensor technology can detect HE4 within the uterine cavity, measured in a surgical setting. We propose to now conduct the first-in-woman clinical trial using this sensor, adding CA125 and p53, during the next funding period. We will also investigate the secondary hypothesis, that p53 detection will improve the ability of the sensor to detect low-volume disease, and possibly pre-invasive disease.
Video credit: Memorial Sloan Kettering Cancer Center