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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05602831
Study type Observational
Source Fudan University
Contact Hao Wen, MD
Phone +86-021-64175590
Email wenhao@shca.org.cn
Status Recruiting
Phase
Start date August 10, 2022
Completion date August 2024

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