The purpose of this study is to determine if ctHPVDNA (circulating tumor HPV DNA) can be used as a non-invasive biomarker for identification and treatment monitoring of cervical cancer by characterizing correlation between plasma ctHPVDNA, urine transrenal HPVDNA (TrHPVDNA) levels and presence of cervical cancer at diagnosis and following definitive intent management.
18 years of age or older on day of signing informed consent
New diagnosis of cervical cancer
Subject is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee
Women who are pregnant
Women with newly diagnosed cervical cancer planning to be treated with surgery or chemoradiation.
Cohort
Prospective
Not listed
Relationship between ctHPVDNA levels in plasma, TrHPVDNA levels in urine, and presence of cervical cancer in women being evaluated in clinic.
We will quantify ctHPVDNA levels in blood plasma and TrHPVDNA in urine from patients with cervical cancer at time of diagnosis.
Change in ctHPVDNA and TrHPVDNA levels following definitive intent therapy for early stage disease.
We will collect bio-specimens and quantify ctHPVDNA and TrHPVDNA levels in plasma and urine, respectively, during their post-treatment visit typically 2-6 weeks post-surgery or last day of treatment visit (chemoradiation).
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