Salivary biomarker Human Beta Defensins 2 and 3 levels in oral cancer patients

Not yet recruiting

• Conditions: Healthy Control without any oral cavity lesion infection ulcers inflammation; Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx,

• Registration Number: CTRI/2025/05/087963
• Lead Sponsor: Dr Akanksha Tiwari

Brief Summary

Oral cancer ranks as the third most prevalentcancer among both sexes in the country is with high disease related mortalityand morbidity. It is the most common cancer among men, accounting for 15.6% ofall cases, and the fourth most common among women, making up 5% of allcancers.  The incidence of oral cancer isIndia is reported to be 1,413,316, with a 5-year prevalence of 3,258,518 caseas per GLOBOCON 2022. The 5-year survival rate for early-stage oralcancer is around 90%, but it drops to 59%-60% for advanced stages. Inmetastatic cases, the survival rate is 52% for the lip and 20% for the floor ofthe mouth. These statistics highlight the importance of earlydetection and treatment to improve survival rates. Early detection of anycancer can result in: higher survival rates, less aggressive treatment withbetter treatment outcomes, cost-effectiveness. Early detection can reduce theoverall cost of healthcare by avoiding more complex and costly treatments.

The identification of protein markers that canpredict the risk of malignant transformation in pre malignantlesions/conditions is a crucial area of research in oncology. By detectingthese markers early, healthcare providers can intervene sooner, potentiallyimproving patient outcomes and reducing the morbidity of the disease. Thisapproach could lead to more personalized treatment plans, better survivalrates, and a decrease in the overall burden of cancer on patients andhealthcare systems.

Humanbeta-defensin is group of cationic antimicrobial peptide of the innate immunesystem, typically found in the highly proliferative epithelial cells of thestratum basale in the oral mucosa. Oral epithelium expresses hBD-1, -2, -3. While hDB-3 specificallyactivates tumour-associated macrophages that promotes tumour development andprogression and it has a crucial role in the tumorigenesis of primary Oral SquamousCell Carcinoma, hBD-2 is known to be upregulated in cancers of oesophagus,cervix and skin and downregulated in colon and oral cancer.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-02-06
• Last Update Posted: 2025-05-05

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

• 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 2Patients 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.

Exclusion Criteria

• •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.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Kasturba Medical College,Manipal; 🇮🇳 Udupi, KARNATAKA, India

Manipal College of Dental Sciences,Manipal; 🇮🇳 Udupi, KARNATAKA, India

Kasturba Medical College,Manipal

🇮🇳Udupi, KARNATAKA, India

Dr Vijetha Shenoy Belle

Principal investigator

9844667820

vijetha.shenoy@manipal.edu