Analysis of HPV and Biomarkers Present in the Biological Fluids of Patients Suffering From Head and Neck Cancer as a Non-invasive Strategy for Detecting Recurrence
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 283
- 试验地点
- 1
- 主要终点
- Identification of biomarkers
研究概览
简要总结
Multicenter, non-interventional, retrospective/prospective biological study on patients affected by head and neck tumors, for which the collection and use of tissue samples, blood and saliva for the detection of HPV-DNA/RNA and miRNA.
详细描述
For each patient they will come collected tissue, blood and saliva samples. In particular, as regards tissue collection, tumor and neighboring tissues will be used healthy specimens taken during surgical removal, according to clinical practice.
The fresh tissues thus collected will be stored in RNA-later before freezing at - 80°C.
Furthermore, blood and saliva samples will be taken at different times, in particular:
i) the day before surgery; ii) the day after surgery (only for blood); iii) at the time of patient discharge (approximately 15 days after surgery); iii) during the check-up visit scheduled to monitor the patient's follow-up (FU): every 3 months for the first 2 years and every 6 months for the following 3 years.
The samples will then be used to carry out nucleic acid extraction, the DNA will instead be used to detect the presence of HPV.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 18 years
- •Patients suffering from squamous cell tumors of the oral cavity, pharynx or larynx
- •Surgical patients with HNSCC primary tumors, who have not had previous tumors in other sites or adjuvant treatments prior to surgery.
- •Availability of material (tissue) and follow-up data for at least one year (retrospective part)
- •Written informed consent (prospective part/patients in follow-up
排除标准
- •Presence of distant metastases at the time of diagnosis
- •Previous head and neck cancer+
- •Second cancer under treatment or follow-up for less than 5 years
结局指标
主要结局
Identification of biomarkers
时间窗: 24 months
The samples that will be collected in this study will be used to carry out nucleic acid extraction. In particular, the extraction of RNA and DNA from tissue samples will be carried out using the "All prep RNA/DNA miRNA universal kit" kit (Qiagen), while from blood and saliva samples it will be carried out respectively through the use of the "DNAeasy blood and tissue kit" (Qiagen) and the "Magmax Total RNA extraction kit" (Thermofisher), following the instructions given in the relevant protocol. The expression of tissue and circulating microRNAs will be evaluated by qRT-PCR analysis using the Taqman method (Life Technology), digital-PCR (dPCR) and Luminex platform (the latter at the IRCSS G Paolo II Tumor Institute of Bari). In particular, the use of dPCR will be necessary for those low-abundance circulating miRNAs which, with the qRT-PCR methodology, are not detectable.
次要结局
- Evaluate HPV-DNA expression as biomarkers.(24 months)
- Evaluate miRNA expression as biomarkers(24 months)