Evaluation of biomarkers in patients with Oral Squamous Cell Carcinoma attending a tertiary care cancer setting in northern India: An Observational study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- 1)The mean serum levels of CYFRA 21-1, IL-8 and MCP-1 will be measured in OSCC patients vs. healthy subjects .
研究概览
简要总结
Oral squamous cell carcinoma (OSCC) is the predominant type of cancer found in the oral cavity. CYFRA 21-1,a soluble fragment derived from Cytokeratin 19 is found in the blood. Elevation of CYFRA 21-1 in oral cancers has shown potential as a diagnostic and prognostic indicator . CYFRA 21-1 may be useful in monitoring treatment response and identifying early signs of relapse in various cancers.Interleukin-8 (IL-8), a CXC chemokine is a pro inflammatory and proangiogenic cytokine acting through CXCR1 and CXCR2 receptors. It also promotes cancer cell proliferation and metastasis .Few studies have observed elevated IL-8 levels in serum and various body fluids of cancer patients. Monocyte chemoattractant protein-1 (MCP-1), also known as CCL2, is a C-C chemokine that plays a pivotal role in inflammation and tumor progression .Elevated MCP-1 levels are associated with poor prognosis in various cancers due to its pro-tumor and immunosuppressive effects
This study aims to evaluate levels CYFRA 21-1, IL-8, MCP-1 in serum of OSCC patients and explore their correlation with disease status and clinicopathological factors. This study is single centered Comparative cross-sectional study with total sample size of 114 participants divided into 2 groups- 57 OSCC patients and 57 healthy subjects. Sample collection will be done after proper consent of the participants who are eligible according to inclusion criteria.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Histologically proven, newly diagnosed cases of Oral Squamous Cell Carcinoma 2 Patients between age 18-70 years.
- •3 Patient willing to give consent.
- •Eligibility criteria for healthy subjects : Healthy individuals between 18-70 years, with no history of malignant, metabolic or autoimmune disorders who are willing to give consent.
排除标准
- •1 Patient not willing to give consent 2 Critically ill patient 3 Pregnant and lactating women 4 Patient with malignancies other than oral squamous cell carcinoma.
- •5 Patients with known autoimmune disorders.
结局指标
主要结局
1)The mean serum levels of CYFRA 21-1, IL-8 and MCP-1 will be measured in OSCC patients vs. healthy subjects .
时间窗: All enrolled participants will be assessed at baseline for the outcomes after sample collection of all participants. There is no follow up in the study. Sample will be collected only once and biomarkers estimated and assessed for outcome.
次要结局
- 1)The distribution of levels of CYFRA 21-1, IL-8 & MCP-1 will be assessed with AJCC PROGNOSTIC STAGE GROUPS (TNM classification) & histopathological staging(2)The distribution of levels of CYFRA 21-1, IL-8 & MCP-1 will be correlated with AJCC PROGNOSTIC STAGE GROUPS (TNM classification) & with histopathological staging.)
研究者
Priyanka Asia
Homi Bhabha Cancer Hospital , VaranasiHomi Bhabha Cancer Hospital , Varanasi