跳至主要内容
临床试验/NCT04743674
NCT04743674招募中不适用

Plasma Circulating Tumor HPVDNA and Transrenal HPVDNA as Minimally Invasive Biomarkers for Cervical Cancer Detection and Surveillance Following Definitive Treatment

UNC Lineberger Comprehensive Cancer Center3 个研究点 分布在 2 个国家目标入组 30 人开始时间: 2024年5月3日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
3
主要终点
Relationship between ctHPVDNA levels in plasma, TrHPVDNA levels in urine, and presence of cervical cancer in women being evaluated in clinic.

研究概览

简要总结

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.

详细描述

Early stage cervical cancer is managed surgically while chemoradiation is the mainstay for treatment of bulky or advanced stage disease. The primary aim of post-treatment surveillance is to detect early recurrences and guide additional therapy. There is no definitive agreement on the best practice for cervical cancer surveillance. Most recurrences are detected based on patient history and physical exam as there is limited data to support cervicovaginal cytology and routine use of imaging in follow up. Novel non-invasive biomarkers are needed to monitor disease status, detect early recurrence and guide personalized treatment decisions. Biospecimens including urine and blood plasma will be collected from patients presenting to the UNC Department of Gynecology Oncology and Multidisciplinary clinics with newly diagnosed cervical cancer to assess for HPVDNA. Archived or residual tissue will also be accessed. For patients who undergo definitive management with surgery or chemoradiation, a post-treatment blood plasma and urine sample will be collected 2-6 weeks after completion and will be compared to pre-therapy ctHPVDNA and TrHPVDNA levels.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • Women who are pregnant

结局指标

主要结局

Relationship between ctHPVDNA levels in plasma, TrHPVDNA levels in urine, and presence of cervical cancer in women being evaluated in clinic.

时间窗: Baseline

We will quantify ctHPVDNA levels in blood plasma and TrHPVDNA in urine from patients with cervical cancer at time of diagnosis.

次要结局

  • Change in ctHPVDNA and TrHPVDNA levels following definitive intent therapy for early stage disease.(2-6 weeks post-treatment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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