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CTRI Number  CTRI/2023/11/059680 [Registered on: 08/11/2023] Trial Registered Prospectively
Last Modified On: 01/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   A study to check the salivary and tissue levels of Chemerin and tissue CD34 for early detection and follow up of Oral Cancer patients  
Scientific Title of Study
Modification(s)  		 Estimation of salivary and tumor derived chemerin and tissue CD34 for early diagnosis and prognostication of patients with oral squamous cell carcinoma 
Trial Acronym  NIL  
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Pavithra V 
Designation  Ph D Student 
Affiliation  Manipal College Of Dental Sciences  
Address  Department Of Oral Pathology and Microbiology,Manipal College Of Dental Sciences,Manipal Academy Of Higher Education,Madhav Nagar,Manipal

Udupi
KARNATAKA
576104
India 
Phone  9791958779  
Fax    
Email  pavithravelusamy2015@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Monica Charlotte Solomon 
Designation  Dean and Professor and Ph D guide 
Affiliation  Manipal College Of Dental Sciences 
Address  Department Of Oral Pathology and Microbiology,Manipal College Of Dental Sciences,Manipal Academy Of Higher Education,Madhav Nagar,Manipal

Udupi
KARNATAKA
576104
India 
Phone  9845701925  
Fax    
Email  monica.charlotte@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Pavithra V 
Designation  Ph D Student 
Affiliation  Manipal College Of Dental Sciences 
Address  Department Of Oral Pathology and Microbiology,Manipal College Of Dental Sciences,Manipal Academy Of Higher Education,Madhav Nagar,Manipal

Udupi
KARNATAKA
576104
India 
Phone  9791958779  
Fax    
Email  pavithravelusamy2015@gmail.com  
 
Source of Monetary or Material Support  
Indian Council Of Medical Research,V. Ramalingaswami Bhawan, P.O. Box No. 4911 Ansari Nagar, New Delhi 110029, India 
Manipal College Of Dental Sceinces,Manipal Academy Of Higher Education,Madhav Nagar,Manipal 576104,Udupi District,Karnataka,India 
 
Primary Sponsor  
Name  Pavithra V 
Address  Ph D student, Department Of Oral Pathology and Microbiology, Manipal College Of Dental Sciences, Manipal Academy Of Higher Education, Madhav Nagar, Manipal 576104,Udupi District, Karnataka, India 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Pavithra V   Manipal College Of Dental Sciences  Department Of Oral Pathology and Microbiology, Manipal College Of Dental Sciences, Manipal Academy Of Higher Education, Madhav Nagar, Manipal 576104,Udupi District, Karnataka, India
Udupi
KARNATAKA 		 9791958779

pavithravelusamy2015@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Clinically Healthy persons without any Systemic diseases  
Patients  (1) ICD-10 Condition: D000||Carcinoma in situ of lip, oral cavity and pharynx, (2) ICD-10 Condition: C00-C14||Malignant neoplasms of lip, oral cavity and pharynx,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  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 
 
ExclusionCriteria 
Details  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).
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
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
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
 		 1 year, 2 year
 
 
Secondary Outcome  
Outcome  TimePoints 
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  
 
Target Sample Size   Total Sample Size="302"
Sample Size from India="302" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   08/11/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="8"
Days="20" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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 

 


 
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