Comparative analysis of qPCR, mRNA ISH and p16 IHC for detection of high risk HPV on fine needle aspirates and core needle biopsies in patients with metastatic squamous cell carcinoma in cervical lymph nodes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- 1)To assess HR HPV status in metastatic squamous cell carcinoma in cervical lymph nodes
研究概览
简要总结
This is a prospective observational study comparing efficacy of pPCR, mRNA ISH and p16 IHC for detection of high risk HPV on fine needle aspirates and core needle biopsies in patients with metastatic squamouc cell carcinoma from oropharynx or unknown primary site to cervical lymph nodes that will be conducted in AIIMS New Delhi and NCI Jhajjar over a period of 2 years. Primary objectives includes assessment of HR HPV status in cervical lymph node metastasis, determination of ideal specimen and best techniqoe for the same. Secondary objective include determination of HR HPV prevalence in squamous cell carcinoma metastasising to cervical lymph nodes.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with cervical lymph node metastasis from oropharyngeal cancer or Carcinoma of Unknown Primary Site 2) FNAC and Core Needle Biopsy available 3) FNAC should have adequate tissue in cell blocks 4) Informed and written consent obtained.
排除标准
- •Non squamous histology 2) Inadequate material for immunohistochemistry and mRNA ISH in cell blocks and biopsies.
结局指标
主要结局
1)To assess HR HPV status in metastatic squamous cell carcinoma in cervical lymph nodes
时间窗: 1 year 8 months
2) To determine the ideal specimen to be obtained for determining HR HPV status in metastatic squamous cell carcinoma to cervical lymph nodes, FNAC v/s Core Needle Biopsy
时间窗: 1 year 8 months
3) To identify the best technique for detection of HR HPV in metastatic squamous cell carcinoma to cervical lymph nodes
时间窗: 1 year 8 months
次要结局
- 1) To determine the prevalence of HR HPV in metastatic squamous cell carcinoma to cervical lymph nodes with or without a clinically or radiologically detected primary lesion in oropharynx(1 year 8 months)
研究者
Dr Anju K T
All India Institute of Medical Sciences New Delhi