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

Saliva as Early Detection Tool for Oral Cancer

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07122128
Acronym
Sal
Enrollment
1000
Registered
2025-08-14
Start date
2021-06-01
Completion date
2026-06-30
Last updated
2025-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DIAGNOSTIC_TESTsaliva a a diagnostic tool for early detection of oral cancer

Three groups will be compared on the basis of cytology, genes and biochemical analysis

Sponsors

Sindh Higher Education Commission
CollaboratorUNKNOWN
Liaquat University of Medical & Health Sciences
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* patients with oral infection

Design outcomes

Primary

MeasureTime frameDescription
salivary cytology1 yearA method will be developed for evaluation of detection of oral cancer
evaluation of telomere length of salivary cells1 yearTelomere length will be evaluation in the saliva of three groups
evaluation of biochemicals of saliva1 yearsaliva of three groups will be compared on the basis of salivary enzymes

Other

MeasureTime frameDescription
A scoring system will be developed for the screening of patients at risk of oral submucous fibrosis2 yearsA scoring system will be developed including cytology, genetic and biochemistry and algorithm will be designed for accurate assessment of the oral cancer

Countries

Pakistan

Contacts

Primary ContactBinafsha Manzoor Prof, SYed, PhD
binafsha.syed@lumhs.edu.pk00923332749201
Backup ContactFasiha Dr Shah, PhD
fasiha.shah@lumhs.edu.pk00923363019144

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026