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CTRI Number  CTRI/2024/03/064727 [Registered on: 22/03/2024] Trial Registered Prospectively
Last Modified On: 21/03/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Comparative study 
Study Design  Single Arm Study 
Public Title of Study   Identification of Microorganism and Biomarkers Present in Oral Cavity in Oral Cancer Patients .  
Scientific Title of Study   Oral Microbiome and Inflammatory markers in Oral Cancer, Pre-Malignancy and Normal Individuals – A Comparative Study. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mr Rajendra babu Ankam 
Designation  Scientific officer  
Affiliation  Homibhabha Cancer Hospital Research center  
Address  Dept ofMicrobiologyHomibhabhaCancer Hospital and Research Center Aganampudi Visakhapatanam

Visakhapatnam
ANDHRA PRADESH
530053
India 
Phone  09848938056  
Fax    
Email  ankamssrajendrababu@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Mr Rajendra babu Ankam 
Designation  Scientific officer  
Affiliation  Homibhabha Cancer Hospital Research center  
Address  Dept ofMicrobiologyHomibhabhaCancer Hospital and Research Center Aganampudi Visakhapatanam

Visakhapatnam
ANDHRA PRADESH
530053
India 
Phone  09848938056  
Fax    
Email  ankamssrajendrababu@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Mr Rajendra babu Ankam 
Designation  Scientific officer  
Affiliation  Homibhabha Cancer Hospital Research center  
Address  Dept ofMicrobiologyHomibhabhaCancer Hospital and Research Center Aganampudi Visakhapatanam

Visakhapatnam
ANDHRA PRADESH
530053
India 
Phone  09848938056  
Fax    
Email  ankamssrajendrababu@gmail.com  
 
Source of Monetary or Material Support  
HOMIBHABHA CANCER HOSPITAL AND RESERCH CENTRE ,VISAKHAPATANAM. 
 
Primary Sponsor  
Name  Tata Memorial Hospital  
Address  Tata Memorial Hospital, Dr.E Borges Road, Prel,Mumbai ,PIN -400012 
Type of Sponsor  Government funding agency 
 
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 
MrAnkam SS Rajendrababu  Homibhabha Cancer Hospital and Research center   Department of microbiology, Aganampudi,Visakhapatanam
Visakhapatnam
ANDHRA PRADESH 
9848938056

ankamssrajendrababu@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
HomibhabhacancerhopitalandResearch centerInstitutional Ethics committe  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: Z00-Z99||Factors influencing health status and contact with health services,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Adults (18 to 70 ) who have been diagnosed with oral dysplasia
Adults (18 to 70 ) or who have been diagnosed with oral malignancies.
Healthy controls (18 to 70 ) free of any oral lesions
 
 
ExclusionCriteria 
Details  •Adults refusing to participate in the study.
•Exclusion criteria for Healthy Participants: Individuals with active dental infection/recent antibiotic use/anti-septic mouthwash use will be excluded from the study.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
• Identifying relative distribution of microbes and oncogenic cytokines in pre-cancer and cancer as compared to healthy environments
• To explore potential utility of microbiome & oncogenic cytokines for early detection of oral cancers.
 
• Identifying relative distribution of microbes and oncogenic cytokines in pre-cancer and cancer as compared to healthy environments
• To explore potential utility of microbiome & oncogenic cytokines for early detection of oral cancers.
 
 
Secondary Outcome  
Outcome  TimePoints 
Identifying relative distribution of microbes and oncogenic cytokines in pre-cancer and cancer as compared to healthy environments
• To explore potential utility of microbiome & oncogenic cytokines for early detection of oral cancers.
 
Identifying relative distribution of microbes and oncogenic cytokines in pre-cancer and cancer as compared to healthy environments
• To explore potential utility of microbiome & oncogenic cytokines for early detection of oral cancers.
 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
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)   29/03/2024 
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="27"
Months="8"
Days="20" 
Recruitment Status of Trial (Global)   Open to Recruitment 
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  

      i.    Title: Oral Microbiome and Oncogenic cytokines in development of Oral Cancer Rationale: Approximately 13% of global cancer burden are directly attributed to infectious agents due to Chronic inflammation and Microbial pathogens.  Human Oral Microbiome Database reports existence of 774 bacterial species. Presence of pro-inflammatory microbes promotes carcinogenetic modulation of cell metabolism resulting in different cytokines that enhance tumor cell proliferation and survival.Pro-inflammatory cytokines are associated with increased oral mucosal damage with higher concentrations of IL-6, IL-8 & TNF-α (oncogenic cytokines) reported in saliva of Oral cancer patients.  Hence, altered microbiomes and salivary oncogenic cytokines, associated with oral inflammation, make potential biomarkers for disease diagnosis.    Novelty: Microbiome profile & oncogenic cytokines, and its association in development of oral cancers are not well established.  We plan to undertake exploratory study to understand their potential role and its association with risk for oral cancer development.   Objectives:Identifying (1) Microbiome and (2) Oncogenic cytokines in Salivary and Buccal mucosal scraping samples in Oral Cancers, Pre – Malignancy & Healthy Individuals.To identify relative distribution of microbes and oncogenic cytokines. Methods·  Whole genome shotgun metagenomic sequencing (platform: Next generation sequencing) will be used to measure overall oral microbiomes followed by Bioinformatics analysis.·         Chemiluminescence & ELISA for Oncogenic cytokines   Expected outcome:  Identifying relative distribution of microbes and oncogenic cytokines in pre-cancer and cancer as compared to healthy environments   To explore potential utility of microbiome & oncogenic cytokines for early detection of oral cancers.

 

 
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