Estimation of salivary and tumor derived chemerin and tissue CD34 for early diagnosis and prognostication of patients with oral squamous cell carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 302
- 试验地点
- 1
- 主要终点
- 1 The levels of chemerin in the saliva of healthy individuals, oral epithelial dysplasia and oral cancer patients can be studied and variability among the groups can help in the early diagnosis of oral squamous cell carcinoma
研究概览
简要总结
This is a retrospective and prospective observational cohort study to estimate the role of salivary and tumor derived chemerin and tissue CD 34 for early diagnosis and prognostication of patients with Oral Squamous Cell Carcinoma ,a single center study to be conducted in India only.
Aims
1 To determine the reliability of immunohistochemical expression of Chemerin and CD 34 for prognostication of Oral Squamous Cell Carcinoma
2 To determine the reliability of salivary Chemerin levels for early detection of Oral Epithelial Dysplasia and Oral Squamous Cell Carcinoma
Objectives
1 To quantify and compare the levels of Chemerin in the saliva of healthy individuals,Oral Epithelial Dysplasia and Oral Squamous Cell Carcinoma patients.
2 To evaluate the immunohistochemical expression of the Chemerin and CD34 in different histological grades of Oral Squamous Cell Carcinoma
3 To correlate the salivary Chemerin and immunohistochemical expression of Chemerin and CD 34 with clinicopathologic parameters of patients with Oral Squamous Cell Carcinoma
4 To correlate the immunohistochemical expression of chemerin and CD 34 in oral squamous cell carcinomas with the follow up status of patients.
The study comprises of two major parts
The first part is a prospective study which includes assessment of salivary levels of chemerin in patients with Oral Squamous Cell Carcinoma and compare with that of Oral Epithelial Dysplasia and the control group.
The second part is a retrospective study which deals with evaluation of immunohistochemical expression of Chemerin and CD 34 in archived formalin fixed paraffin embedded tissue sections of Oral Squamous Cell Carcinoma patients and further follow up of patients for prognostication will be done
Inclusion Criteria for salivary part of the study
Group 1 Well, Moderate and Poorly differentiated oral squamous cell carcinoma which is confirmed by clinical and histopathological examination 43 patients
Group 2 Premalignant lesions which is confirmed by clinical and histopathological examination 32 patients
Group 3 Clinically Healthy individuals without any systemic diseases and oral lesions 43 patients
Total number of patients for salivary part of the study 118 patients
Inclusion Criteria for tissue part of the study
Group 1 Well differentiated Oral Squamous Cell Carcinoma which is confirmed by clinical and histopathological examination 102 samples
Group 2 Moderate and Poorly differentiated Oral Squamous Cell Carcinoma which is confirmed by clinical and histopathological examination 82 samples
Total sample size for tissue part of the study is 184
Total Number of samples required for the study including the tissue and the saliva samples is 302
Exclusion Criteria
Patients with systemic diseases, inflammatory oral lesions, periodontal disease
Prior history of other malignancy.
Prior treatment in the form of chemotherapy, radiotherapy
Pregnancy, Lactation
Patients who are obese (BMI ≥30)
Analysis of the biomarker
The salivary Chemerin will be measured by using Enzyme Linked Immunosorbent Assay. The levels of salivary Chemerin measured will be quantified and compared across the study population for early diagnosis of Oral Squamous Cell Carcinoma
The tissue Chemerin and CD 34 will be evaluated by immunohistochemistry technique. The expression of marker will be analyzed in a semiquantitative manner by two independent observers having blinded the clinical details of the cases.
Primary Outcome
Salivary levels of Chemerin helps in the early diagnosis and immunohistochemical expression of Chemerin and CD 34 helps in the prognostication of patients with Oral Squamous Cell Carcinoma at 2 years 8 months
Secondary Outcome
The salivary chemerin and the immunohistochemical expression of chemerin,CD34 with clinicopathological parameters of patients with Oral Squamous Cell Carcinoma can be compared at 2 years 8 months
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- All
入选标准
- •For Tissues Group 1 Well Diffrentiated Oral Squamous Cell Carcinoma Group2 Moderate and Poorly Diffrentiated Oral Squamous Cell Carcinoma For Saliva Group 1 Well,Moderate,Poorly differentiated and recurrent cases of Oral Squamous Cell Carcinoma Group 2 Premalignant lesions showing moderate and severe dysplasia Group 3 Clinically healthy individuals without any systemic diseases.
排除标准
- •Patients with systemic diseases, inflammatory oral lesions, periodontal disease, Prior history of other malignancy, Prior treatment in the form of chemotherapy, radiotherapy, Pregnancy, Lactating mothers, Patients who are obese (BMI ≥30).
结局指标
主要结局
1 The levels of chemerin in the saliva of healthy individuals, oral epithelial dysplasia and oral cancer patients can be studied and variability among the groups can help in the early diagnosis of oral squamous cell carcinoma
时间窗: 1 year, 2 year
2 The immunohistochemical expression of the chemerin and CD34 in different histological grades of Oral Squamous Cell Carcinoma can be observed and prognostication of patients can be studied
时间窗: 1 year, 2 year
次要结局
- The salivary chemerin levels, immunohistochemical expression of chemerin,CD34 with clinicopathological parameters of patients with Oral Squamous Cell Carcinoma can be stratified into low risk,high risk groups for early diagnosis,prognostication.(1 Year, 2 year)