CTRI Number |
CTRI/2025/05/087963 [Registered on: 30/05/2025] Trial Registered Prospectively |
Last Modified On: |
05/05/2025 |
Post Graduate Thesis |
Yes |
Type of Trial |
Observational |
Type of Study
|
Cross Sectional Study |
Study Design |
Other |
Public Title of Study
|
Salivary biomarker Human Beta Defensins 2 and 3 levels in oral cancer patients |
Scientific Title of Study
|
A comparative analysis of Salivary human beta defensin 2 and 3 as a biomarker in diagnosis of Oral potentially malignant disorders and Oral cancer cases. |
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 Akanksha Tiwari |
Designation |
Post Graduate Student |
Affiliation |
Manipal College Of Dental Sciences |
Address |
Department Of Oral Medicine and Radiology
Manipal College Of Dental Sciences Manipal
Madhav Nagar Eshwar Nagar
Karnataka 576104
Udupi KARNATAKA 576104 India |
Phone |
09811494122 |
Fax |
|
Email |
akanksha.tiwari1898@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Yogesh Chhaparwal |
Designation |
Professor and Head |
Affiliation |
Manipal College Of Dental Sciences,Manipal |
Address |
Department Of Oral Medicine and Radiology
Manipal College Of Dental Sciences Manipal
Madhav Nagar Eshwar Nagar
Karnataka 576104
Udupi KARNATAKA 576104 India |
Phone |
9986454730 |
Fax |
|
Email |
yogesh.chhaparwal@manipal.edu |
|
Details of Contact Person Public Query
|
Name |
Dr Akanksha Tiwari |
Designation |
Post Graduate Student |
Affiliation |
Manipal College Of Dental Sciences |
Address |
Department Of Oral Medicine and Radiology
Manipal College Of Dental Sciences Manipal
Madhav Nagar Eshwar Nagar
Karnataka 576104
KARNATAKA 576104 India |
Phone |
09811494122 |
Fax |
|
Email |
akanksha.tiwari1898@gmail.com |
|
Source of Monetary or Material Support
|
Department of Oral Medicine and Radiology
Manipal College of Dental Sciences
Manipal |
|
Primary Sponsor
|
Name |
Dr Akanksha Tiwari |
Address |
Department of Oral Medicine and Radiology
Manipal College of Dental Sciences
Madhav Nagar Eshwar Nagar
Manipal |
Type of Sponsor |
Other [Primary Investigator] |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 2 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Vijetha Shenoy Belle |
Kasturba Medical College,Manipal |
Department of Biochemistry
Udupi KARNATAKA |
9844667820
vijetha.shenoy@manipal.edu |
Dr Akanksha Tiwari |
Manipal College of Dental Sciences,Manipal |
Department of Oral Medicine and Radiology, Room No.1
Udupi KARNATAKA |
9811494122
akanksha.tiwari1898@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
KasturbaMedicalCollegeandKasturbaHospitalInstitutionalEthicsCommittee2 |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
Healthy Control without any oral cavity lesion infection ulcers inflammation |
Patients |
(1) ICD-10 Condition: C148||Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Nil |
Nil |
|
Inclusion Criteria
|
Age From |
20.00 Year(s) |
Age To |
80.00 Year(s) |
Gender |
Both |
Details |
Group 1 Patients having habit of betel quid chewing with areca nut chewing, smoking and smokeless forms of tobacco consumption without any clinical evidence of lesion in oral cavity aged between 20 to 80 years.
Group 2 Patients with any inflammatory and infectious oral conditions like moderate to severe periodontitis, ulcers aged between 20 to 80 years.
Group 3 Inclusion criteria for Oral Potentially Malignant Disorders-
1 Clinically diagnosed cases of leukoplakia/non homogenous leukoplakia and or erythroplakia with histopathological diagnosis of hyper or para keratosis with or without dysplasia falling withing age group of 20-80 years
2 Clinically diagnosed cases of OSMF falling withing age group of 20-80 years.
3 Clinically and histo-pathologically proven cases of erosive variant of oral lichen planus of patients within age group 20-80 years.
Inclusion criteria for oral cancer group-
4 Histopathologically diagnosed cases of Oral squamous cell carcinoma, Invasive carcinoma and carcinoma insitu in patients aged between 20-80 years.
Inclusion criteria for control group-
Patients with no oral habits of tobacco consumption, patients in good systemic health, not taking any medication for systemic illnesses aged between 20-80 years.
Patients who demonstrate good oral hygiene and were free from any oral infection or inflammation like oral ulcers or inflamed gums aged between 20-80 years.
|
|
ExclusionCriteria |
Details |
• Patients who do not give consent to participate in the study.
• Patients who have underlying systemic diseases, other malignancies apart from Oral squamous cell carcinoma.
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
The Up regulation and/or down regulation of these salivary defensin biomarkers may validate its efficacy as a useful early screening or diagnostic tool. |
Outcomes will be assessed quarterly and Final Outcome will be assessed after 18 months |
|
Secondary Outcome
|
Outcome |
TimePoints |
NIL |
NIL |
|
Target Sample Size
|
Total Sample Size="84" Sample Size from India="84"
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)
|
02/06/2025 |
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="1" Months="6" 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
|
Oral cancer ranks as the third most prevalent
cancer among both sexes in the country is with high disease related mortality
and morbidity. It is the most common cancer among men, accounting for 15.6% of
all cases, and the fourth most common among women, making up 5% of all
cancers. The incidence of oral cancer is
India is reported to be 1,413,316, with a 5-year prevalence of 3,258,518 case
as per GLOBOCON 2022. The 5-year survival rate for early-stage oral
cancer is around 90%, but it drops to 59%-60% for advanced stages. In
metastatic cases, the survival rate is 52% for the lip and 20% for the floor of
the mouth. These statistics highlight the importance of early
detection and treatment to improve survival rates. Early detection of any
cancer can result in: higher survival rates, less aggressive treatment with
better treatment outcomes, cost-effectiveness. Early detection can reduce the
overall cost of healthcare by avoiding more complex and costly treatments. The identification of protein markers that can
predict the risk of malignant transformation in pre malignant
lesions/conditions is a crucial area of research in oncology. By detecting
these markers early, healthcare providers can intervene sooner, potentially
improving patient outcomes and reducing the morbidity of the disease. This
approach could lead to more personalized treatment plans, better survival
rates, and a decrease in the overall burden of cancer on patients and
healthcare systems. Human
beta-defensin is group of cationic antimicrobial peptide of the innate immune
system, typically found in the highly proliferative epithelial cells of the
stratum basale in the oral mucosa. Oral epithelium expresses hBD-1, -2, -3. While hDB-3 specifically
activates tumour-associated macrophages that promotes tumour development and
progression and it has a crucial role in the tumorigenesis of primary Oral Squamous
Cell Carcinoma, hBD-2 is known to be upregulated in cancers of oesophagus,
cervix and skin and downregulated in colon and oral cancer. |