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

ConditionThe Study Focuses on the Saliva as Potential Source of Early Detection of Oral Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorLiaquat University of Medical & Health Sciences

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

healthy volunteers

patients with oral submucous fibrosis

patients with biopsy proven oral cancer

Disqualifiers

patients with oral infection

Trial population

The three groups will be recruited: healthy volunteers with unremarkable oral examination, patients with oral submucous fibrosis regardless of mouth opening and biopsy proven oral cancer patients.

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

  • saliva a a diagnostic tool for early detection of oral cancer

    Diagnostic test

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

Treatment groups

1,000 Participants
are divided into 3 treatment groups
Group A: Normal healthy volunteers1 intervention
Group B: oral submucous fibrosis1 intervention
Group C: oral cancer patients1 intervention

Trial outcomes

Primary outcomes

1

salivary cytology

A method will be developed for evaluation of detection of oral cancer

Time frame
1 year
2

evaluation of telomere length of salivary cells

Telomere length will be evaluation in the saliva of three groups

Time frame
1 year
3

evaluation of biochemicals of saliva

saliva of three groups will be compared on the basis of salivary enzymes

Time frame
1 year

Secondary outcomes

Other outcomes

1

A scoring system will be developed for the screening of patients at risk of oral submucous fibrosis

A scoring system will be developed including cytology, genetic and biochemistry and algorithm will be designed for accurate assessment of the oral cancer

Time frame
2 years

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Medical Research CenterRecruiting Jāmshoro, SinchPakistanPakistan

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Liaquat University of Medical & Health Sciences

Lead sponsor

Sindh Higher Education Commission

Collaborator

Source ClinicalTrials.gov
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