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

Liaquat University of Medical & Health Sciences

Status: Enrolling

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

Treatments: Diagnostic Test: saliva a a diagnostic tool for early detection of oral cancer

Study type: Observational

Funder types: Other

Identifiers

NCT07122128

Sal001 (Other Identifier)

SalivaP01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• patients with oral infection

Trial design

1,000 participants in 3 patient groups

Normal healthy volunteers

Description:

oral examination will be done, those without any oral infection, oral submucous fibrosis or cancer will be included in health volunteer group

Treatment:

Diagnostic Test: saliva a a diagnostic tool for early detection of oral cancer

oral submucous fibrosis

Description:

Patients with oral submucous fibrosis both with and without limited mouth opening

Treatment:

Diagnostic Test: saliva a a diagnostic tool for early detection of oral cancer

oral cancer patients

Description:

patients with biopsy proven oral cancer

Treatment:

Diagnostic Test: saliva a a diagnostic tool for early detection of oral cancer