跳至主要内容
临床试验/NCT04683549
NCT04683549Unknown不适用

HPV Serum Level and FDG PET CT in Patients With Cervical Cancer Treated With Radical Radiochemotherapy (HPV-RICCO - HPV Relation in Cervical Cancer Outcomes)

The Greater Poland Cancer Centre1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年6月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
30
试验地点
1
主要终点
local control

研究概览

简要总结

The main purpose of the study is to describe changes in plasma HPV DNA levels in patients with locally advanced cervical cancer during radical radiochemotherapy (CRT) and to correlate changes with response to treatment. Monitoring of the response to treatment will also be assessed in FDG PET CT imaging.

详细描述

Ninety-five per cent of cervical cancer cases are caused by persistent infections with carcinogenic HPVs. Locally advanced stage IB2 to IVA cervical cancers are treated with definitive chemoradiation therapy (CRT). Despite known clinical prognostic factors of poor treatment outcome such as advanced stage and positive nodal status, we still don't know predictors of relapse.

HPV status will be assessed in the neoplastic tissue and DNA from the blood serum of patients with cervical cancer will be isolated and analyzed by real-time PCR. Plasma HPV DNA would identify patients with residual disease after CRT due to persistent detectable HPV. This would earlier detect high risk patients who would benefit from adjuvant therapy.

While metabolic response in post - therapy FDG PET CT is predictive of survival, there is usually 3 months waiting period time needed to perform this imaging. This pilot study will provide preliminary estimates of the correlation between plasma HPV DNA level, PET finding and clinical outcome in polish cervical cancer patients.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Age Limits: more than 18Y Histologically confirmed squamous cell carcinoma, FIGO stage IB-IVA planned for radical radiochemotherapy Eastern Cooperative Oncology Group (ECOG) performance status 0,1,2

排除标准

  • •Patients who have received any anticancer treatment for their cervical cancer. Eastern Cooperative Oncology Group (ECOG) performance status > 2 Other cervical cancer tumor histologies (e.g. small cell, serous) Contraindications to 18FDG PET-CT Contraindication to radiochemotherapy Known pregnancy or lactating

研究组 & 干预措施

One-Arm HPV serum level and FDG PET CT

Other

HPV serum level and FDG PET CT in patients with cervical cancer treated with radical radiochemotherapy

干预措施: HPV serum level and FDG PET CT in patients with cervical cancer treated with radical radiochemotherapy (Diagnostic Test)

结局指标

主要结局

local control

时间窗: 18 months

Response to treatment

时间窗: 6 months

次要结局

  • Progression-free survival(18 months)
  • Plasma HPV DNA levels(Up to 3 months)

研究者

发起方
The Greater Poland Cancer Centre
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验