跳至主要内容
临床试验/NCT05918510
NCT05918510招募中不适用

Observational Study of Viral BIOmarkers and microRNAs in Tumors Orofarynx and Occult Tumors Positive for Papilloma Virus

Regina Elena Cancer Institute1 个研究点 分布在 1 个国家目标入组 142 人开始时间: 2022年4月4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
142
试验地点
1
主要终点
Accouracy

研究概览

简要总结

Based on the evidence summarized in the introduction, the clinician hypothesize that the detection of the presence and expression of HPV-DNA, certain miRNAs, and a certain mutational profile in the tissues and biological fluids of these patients, may have important prognostic and diagnostic value not only in HPV-related OPSCCs but also in HPV+ occult T. Accordingly, this study aims to aim to better characterize their potential as biomarkers and to detect the possibility of their their use to implement the sensitivity and specificity of radiological methodologies (PET-CT and MRI), already in use in clinical practice, for monitoring disease progression in this specific subgroup. Finally, by using the collected material to generate organoids and Patient Derived Xenograft (PDX), the study also aims to identify possible new molecular drugs, which could solve the problem of resistance to radiochemotherapy.

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
All
接受健康志愿者

入选标准

  • Squamous cell carcinomas of the oropharynx and occult neoplasms with lymph node metastases laterocervical cytologically positive for squamous cell carcinoma treated with TORS or RT or RT/CT
  • Age > 18 years
  • ECOG performance status <_ 2
  • Ability to follow study procedures and complete questionnaires
  • Signature of informed consent

排除标准

  • Presence of distant metastases at the time of diagnosis
  • Previous cancer of the head and neck district
  • Second tumor in therapy or follow-up for less than 5 years

结局指标

主要结局

Accouracy

时间窗: Baseline

Investigating the kinetics of HPV-DNA and miRNAs in patients with oropharyngeal and occult T tumors with laterocervical metastasis. Conducting this study will allow us to collect the information needed to be able to generate hypotheses and design a subsequent larger study.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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