EVALUATION OF SALIVA AS LIQUID BIOPSY FOR EARLY DETECTION OF ORAL CANCER IN PATIENTS WITH ORAL-SUBMUCOUS FIBROSIS (OSMF)

Recruiting

• Conditions: The Study Focuses on the Saliva as Potential Source of Early Detection of Oral Cancer

• Registration Number: NCT07122128
• Lead Sponsor: Liaquat University of Medical & Health Sciences

Brief Summary

Oral cancer is the top cancer in Pakistan, accounting for 27%, and it has a high mortality rate due to late-stage diagnosis. It primarily affects the lips, tongue, cheeks, and floor of the mouth. Major risk factor for oral cancer development is pan supari chhaliya chewing.

Patients often develop a pre-malignant condition, oral submucous fibrosis, resulting in limited mouth opening. Thus, patients are diagnosed at an advanced level and poor survival. Therefore, saliva appears a potential mode of evaluation for early detection. This project aims to evaluate salivary cells, genes and biochemistry of the saliva among health volunteers and compare it with that of the patients with oral submucous fibrosis and oral cancer.

Detailed Description

The project aims to evaluate salivary cytology, genes and biochemistry of the healthy normal population and compare it with that of the oral submucous fibrosis and oral cancer. For salivary experiments 3 cc of fresh saliva will be collected and analysed.

Study Timeline

• Study Start: 2021-06-01
• Status Verified: 2025-08
• Study First Submitted: 2025-08-07
• Study First Submitted QC: 2025-08-07
• Last Update Submitted: 2025-08-07
• Study First Posted: 2025-08-14
• Last Update Posted: 2025-08-14
• Primary Completion: 2025-12-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• healthy volunteers
• patients with oral submucous fibrosis
• patients with biopsy proven oral cancer

Exclusion Criteria

• patients with oral infection

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
salivary cytology	1 year	A method will be developed for evaluation of detection of oral cancer
evaluation of biochemicals of saliva	1 year	saliva of three groups will be compared on the basis of salivary enzymes
evaluation of telomere length of salivary cells	1 year	Telomere length will be evaluation in the saliva of three groups

Trial Locations

Locations (1)

Medical Research Center; 🇵🇰 Jāmshoro, Sinch, Pakistan