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Brief Title: Assessment of Prognosis Using Peripheral Blood Circulating Tumor DNA in Patients With Cervical Cancer
Official Title: Using Peripheral Blood Circulating Tumor DNA (ctDNA) Based Human Papillomavirus (HPV) and Genetic Variant Test to Assess the Prognosis of Surgery or Radical Chemoradiotherapy in Patients With Locally Advanced Cervical Cancer
Study ID: NCT05602831
Brief Summary: This observational study is conducted to assess the value of using peripheral blood ctDNA to detect dynamic changes in HPV and genetic variants in predicting the prognosis of patients with locally advanced cervical cancer, as compared with traditional imaging and tumor markers.
Detailed Description: The goal of this study is to assess the prognostic value of ctDNA HPV and gene variant clearance in peripheral blood. Two cohorts will be enrolled: operable group and radical chemoradiotherapy group. After enrollment, patients will receive standard treatment and follow-up strategy. Peripheral blood samples will be collected from 2 cohorts of patients before treatment and at different time points after starting treatment. Baseline surgical or puncture tissues will be also obtained. Peripheral blood ctDNA and baseline tissues will be tested for HPV copy number based on ddPCR and genetic variation based on next-generation sequencing (NGS). Finally, the correlation of ctDNA HPV and genetic variation clearance with patients prognosis and its value for recurrence monitoring compared to traditional tumor markers and imaging examination will be analyzed.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Fudan University Shanghai Cancer Center, Shanghai, , China