Multidimensional Assessment of Virus-associated Head and Neck Cancer Patients for the Discovery of Predictive Biomarkers to Guide Clinical Intervention
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Observe the kinetics of HPV-DNA levels circulating in the blood
研究概览
简要总结
Prospective pilot study, non-interventional, of a biological/radiological nature, which involves the collection of tissue samples, and blood from patients suffering from squamous cell carcinoma of the oropharynx OPSCC for detection of HPV-DNA/RNA and immuno-phenotypic analysis of T cells, study of extracellular vesicles, and dosages of cytokines and chemokines involved in the immune response
详细描述
The study involves the collection of tissue samples, and blood from patients suffering from squamous cell carcinoma of the oropharynx OPSCC for detection of HPV-DNA/RNA and immuno-phenotypic analysis of T cells, study of extracellular vesicles, and dosages of cytokines and chemokines involved in the immune response. Radiological images will be collected during diagnosis, treatment and the care path, with exploratory and research purposes only, without the results modifying the care path and the diagnostic-therapeutic process of the patients participants. Molecular analyzes and/or material extraction will not be conducted genomic/protein of any kind. The objective is to observe the kinetics of the levels of HPV-DNA circulating in the blood patients with oropharynx cancers HPV related to the diagnosis and during the care pathway patient. The blood of HPV-negative patients will be tested to confirm that there are no copies of circulating HPV-DNA. The aim is to collect the information necessary to improve understanding and managing HPV-associated OPSCC.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- 否
入选标准
- •Squamous cell carcinomas of the oropharynx (OPSCC) candidates for surgical
- •Age > 18 years
- •ECOG performance status <_ 2
- •Signature of informed consent (to participate in the study and data processing)
排除标准
- •Presence of distant metastases at the time of diagnosis
- •Previous head and neck cancer
结局指标
主要结局
Observe the kinetics of HPV-DNA levels circulating in the blood
时间窗: 24 months
ctHPV DNA levels will be measured by digital PCR, 8 mL of blood will be collected in DNA BCT Streck tubes. The blood will be centrifuged a room temperature and frozen at -80°C until extraction. Total ctDNA will be extracted from 5 mL of plasma using the QIAamp Circulating Nucleic Acid Kit and will be quantified with a Qubit fluorometer. The ddPCR will be performed on a QX-200 platform and analyzed with QuantaSoft software v1.7.4.0917. Probes will be used for conserved regions of HPV E6 for HPV 16. Samples will be run with 5 cfDNA input to 10 ng and titered to optimize ddPCR performance, with a range of 1 to 20 ng of cfDNA total loaded per well. These reactions will be added to a DG8 cartridge along with 60mL of droplet generating oil. The drops will then be transferred to a plate from 96 wells and subjected to thermal cycles with the following conditions: 5 min at 95°C, 40 cycles at 94°C for 30 seconds, 55°C for 1 minute followed by 98°C for 10 min.
次要结局
- Isolation of extracellular vesicles(24 months)
- Immuno-phenotyping at the tissue and blood level(24 months)