Medical Research Center
Jāmshoro, Sinch, Pakistan
Location status: Recruiting
Recruiting
NCT Number: NCT07122128
EVALUATION OF SALIVA AS LIQUID BIOPSY FOR EARLY DETECTION OF ORAL CANCER IN PATIENTS WITH ORAL-SUBMUCOUS FIBROSIS (OSMF)
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.
Recruiting
Interested in participating?
Request InfoKey information
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- healthy volunteers
- patients with oral submucous fibrosis
- patients with biopsy proven oral cancer
Exclusion criteria
- patients with oral infection
Treatment and study plan
saliva a a diagnostic tool for early detection of oral cancer
Diagnostic TestThree groups will be compared on the basis of cytology, genes and biochemical analysis
Primary outcomes
-
salivary cytology
Time frame: 1 year
A method will be developed for evaluation of detection of oral cancer
-
evaluation of telomere length of salivary cells
Time frame: 1 year
Telomere length will be evaluation in the saliva of three groups
-
evaluation of biochemicals of saliva
Time frame: 1 year
saliva of three groups will be compared on the basis of salivary enzymes
Other outcomes
-
A scoring system will be developed for the screening of patients at risk of oral submucous fibrosis
Time frame: 2 years
A scoring system will be developed including cytology, genetic and biochemistry and algorithm will be designed for accurate assessment of the oral cancer
Study contacts
Contact information is provided by the study sponsor or research team.
Binafsha Manzoor Prof, SYed, PhD
CONTACT
Fasiha Dr Shah, PhD
CONTACT
Sponsors and collaborators
Lead sponsor
Liaquat University of Medical & Health Sciences
Other
Collaborators
- Sindh Higher Education Commission
Registry information
Official study title
Saliva as Early Detection Tool for Oral Cancer
Acronym: Sal
Important dates
- Study start
- 2021
- Primary completion
- 2025
- Study completion
- 2026
- First posted
- Aug 14, 2025
- Registry last updated
- Aug 14, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.