| CTRI Number |
CTRI/2022/08/045074 [Registered on: 30/08/2022] Trial Registered Prospectively |
| Last Modified On: |
24/08/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Association between the microbiome and oral cancer; a comparative
study from South India. |
|
Scientific Title of Study
|
Association between the microbiome and oral cancer; a comparative
study from South India. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anirudh Jeedigunta |
| Designation |
Medical student |
| Affiliation |
Kasturba Medical College, Manipal MAHE |
| Address |
Kasturba Medical College, Tiger Circle Road, Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
09740394228 |
| Fax |
|
| Email |
anirudh.jeedigunta@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Devaraja K |
| Designation |
Associate professor ( Department of Otorhinolaryngology) |
| Affiliation |
Kasturba Medical College, Manipal MAHE |
| Address |
Department of ENT, New OPD block,Kasturba Hospital ,Tiger Circle Road, Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9999662597 |
| Fax |
|
| Email |
devaraja.k@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Anirudh Jeedigunta |
| Designation |
Medical student |
| Affiliation |
Kasturba Medical College, Manipal MAHE |
| Address |
Kasturba Medical College, Tiger Circle Road, Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
09740394228 |
| Fax |
|
| Email |
anirudh.jeedigunta@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Cell and Molecular Biology,
Manipal School of Life Sciences |
| ICMR - Short term Studentship |
|
|
Primary Sponsor
|
| Name |
Anirudh Jeedigunta |
| Address |
College Office, UG Section
Kasturba Medical College, Manipal
Manipal Academy of Higher Education
Manipal, India-576104 |
| Type of Sponsor |
Other [Investigator-Initiated] |
|
|
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 |
| Anirudh Jeedigunta |
Kasturba Medical College Manipal |
Department of ENT OPD,4th floor New OPD block,Kasturba Hospital ,Tiger Circle Road, Madhav Nagar, Manipal
Udupi
KARNATAKA |
9740394228
anirudh.jeedigunta@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-C14||Malignant neoplasms of lip, oral cavity and pharynx, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Treatment naïve cases of oral cancer hailing from South India, irrespective of the gender of patient and site or stage of oral cancer, who would be managed at the tertiary care hospital attached to our medical school |
|
| ExclusionCriteria |
| Details |
Patients aged less than 18 years, Human Immunodeficiency Virus
infection, pre-existing local mucosal diseases or autoimmune diseases, and recipients of
chemotherapy or any other medications that would alter the oral microbiome. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The outcome measure used to compare the microbial profile between the study specimen and control specimen is the relative abundance of various bacteria. |
The surgical samples will be collected, stored and subsequently analysed for its microbial profile at a single time point (cross-sectional study) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
05/09/2022 |
| 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="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not published as of yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Title of the Project - Association between microbiome and oral cancer ; a comparative study from South India
There have been many recent studies linking dysbiosis of the oral microbiome with oral carcinogenesis. This creates potential clinical implications with regards to the prognostic, therapeutic and preventive aspects of the management of oral cancer. Just like the Human papilloma virus in oropharyngeal cancer, the oral microbiome profile, or a specific few bacteria may eventually serve as prognostic markers in oral cancer, which can help in improvisation of therapeutic strategies . There have been many studies published related to this topic but to our knowledge there have been no studies profiling this association in the South Indian population with the characteristics of the oral microbiome depending on the local dietary habits and tobacco consumption practices. As a stepping stone towards the objective of profiling microbiomes of local populations in multiple communities, in order to validate its role in oral carcinogenesis, this pilot study evaluates the relative microbial abundance between oral cancer and matched normal tissue in a small cohort of South Indian patients.
Objectives of the study - - To define oral microbiota associated with oral cancer tissue in South Indian patients and to analyse the oral microbial profile as per smokeless tobacco usage and size/ location of tumour in oral cavity - This study will help establish oral microbiome profile in normal tissue and oral cancer in a cohort of South Indian Population for the first time. Also, this study will help in understanding the association between oral dysbiosis and carcinogenesis in our set of patients who have a particular risk profile - Th results of this study are likely to serve as reference data for more extensive and hypothesis driven studies to be conducted in the future.
Description of procedure - For this study , both study specimen and the corresponding matched normal sample (normal mucosa on the contralateral side) will be collected from the same patient on the surgical table, just before full surgical excision is initiated. The specimens would be stored in a preservation solution and transported to the life sciences lab within the same campus. In the life sciences lab, the genomic DNA would be extracted from the tissue specimens using a DNA extraction kit. The extracted DNA would be amplified, sequenced and analysed.
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