| 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
|
|
|
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
|
|
|
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. |