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CTRI Number  CTRI/2025/06/089859 [Registered on: 30/06/2025] Trial Registered Prospectively
Last Modified On: 30/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Diagnostic
Screening
Dentistry 
Study Design  Other 
Public Title of Study   Blood Analysis of macrophages in Patients suffering from Oral Cancer along with histological examination. 
Scientific Title of Study   Haematological Assessment of the presence of Tumor Associated Macrophages (TAMs) with Immunohistochemical marker and Histological Special Stain in different grades of 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  Dr Hardavi Dholakia 
Designation  Post Graduate Student  
Affiliation  Manubhai Patel Dental College and Hospital  
Address  Ground Floor Department of Oral and Maxillofacial Pathology and Microbiology Manubhai Patel Dental College and Hospital Vishwajyoti Ashram Nr Vidyakunj School Munjmahuda Vadodara

Vadodara
GUJARAT
390011
India 
Phone  7567336774  
Fax    
Email  hardvidholakia@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Dharmesh Vasavada 
Designation  Professor 
Affiliation  Manubhai Patel Dental College and Hospital 
Address  Ground Floor Department of Oral and Maxillofacial Pathology and Microbiology Manubhai Patel Dental College and Hospital Vishwajyoti Ashram Nr Vidyakunj School Munjmahuda Vadodara

Vadodara
GUJARAT
390011
India 
Phone  9429534246  
Fax    
Email  dharmeshvasavada@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Dharmesh Vasavada 
Designation  Professor 
Affiliation  Manubhai Patel Dental College and Hospital 
Address  Ground Floor Department of Oral and Maxillofacial Pathology and Microbiology Manubhai Patel Dental College and Hospital Vishwajyoti Ashram Nr Vidyakunj School Munjmahuda Vadodara

Vadodara
GUJARAT
390011
India 
Phone  9429534246  
Fax    
Email  dharmeshvasavada@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr. Hardavi Dholakia  
Address  Ground floor Department of Oral and Maxillofacial Pathology and Microbiology Manubhai Patel Dental College and Hospital Vishwajyoti Ashram Nr Vidyakunj School Munjmahuda Vadodara  
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 
Dr Hardavi Dholakia   Manubhai Patel Dental College and Hospital and ORI   Ground floor Department of Oral and Maxillofacial Pathology and Microbiology Manubhai Patel Dental College and Hospital Vishwajyoti Ashram Nr Vidyakunj School Munjmahuda Vadodara College and Hospital
Vadodara
GUJARAT 		 7567336774

hardvidholakia@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee for Research, Manubhai Patel Dental College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C148||Malignant neoplasm of overlappingsites 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  Blood samples of Oral Squamous Cell Carcinoma Patients  Examination of macrophages in blood samples of Patients diagnosed with Oral Squamous Cell Carcinoma 
Comparator Agent  Non specific esterase enzyme with immunohistochemical marker and histological special stain  Comparing the efficacy of non specific esterase enzyme in detecting the presence of tumor associated macrophages in blood and comparing it with immunohistochemical marker and histological special stain. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Patients with non-healing ulcers, ulcero – proliferative growth and histopathologically diagnosed as OSCC.
Patients with tobacco/smoking associated habits and with non-healing ulcero-proliferative growth in buccal mucosa of patients.
 
 
ExclusionCriteria 
Details  Patients who have already undergone surgical resection of the lesion.
Biopsy specimen of patients where malignancy is not detected.
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Increased macrophages in peripheral blood smear   20 months 
 
Secondary Outcome  
Outcome  TimePoints 
Tissue taking up the Perls Prussian Blue Stain suggestive of the presence of macrophages in histological specimen  20 months 
 
Target Sample Size   Total Sample Size="22"
Sample Size from India="22" 
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)   25/07/2025 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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   Determining the presence of Tumor Associated Macrophages (TAMs) in blood using Non Specific esterase or Alpha naphthyl acetate esterase and comparing it with the Immunohistochemical marker and Histological Special Stain - Perls Prussian Blue Stain in different grades of Oral Squamous Cell Carcinoma. 
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