This invention is a collection of immunological checkpoint proteins and physiological markers to diagnose and potentially monitor treatments for cervical cancer. This biomarker panel would be taken using the cervicovaginal lavage method, which is less invasive than other sampling methods for cervical cancer. This diagnostic test could be used not only for diagnosing cervical cancer, but also monitoring a patient's response to immunotherapy. It could also be utilized in precision medicine to determine which immunotherapeutic regimen would be the most effective for a particular individual.
Background:
Cervical cancer is the fourth most frequent cancer in women with an estimated 570,000 new cases in 2018, representing 6.6% of all female cancers. The overall five-year survival for all stages of cervical cancer is only 68% with overall survival for advanced cervical cancer being 16.8 months. There are only two FDA approved immunotherapy options for the treatment of recurred or metastasized cervical cancer: anti- VEGF antibodies and immune checkpoint inhibitor targeting PD-1. However, only 20% of patients respond positively to anti-PD-1 treatment. A large portion of those that do respond to treatment also have large toxicity issues. A collection of immunological biomarkers sampled from vaginal cells could help decrease both incidence of cancer and morbidity by helping create customized therapeutic treatment regimens for patients.
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