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Recruiting NCT07122128

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

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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: saliva a a diagnostic tool for early detection of oral cancer.
Who it may be relevant to
Registry conditions: The Study Focuses on the Saliva as Potential Source of Early Detection of Oral Cancer. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Pakistan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Saliva as Early Detection Tool for Oral Cancer

Overview

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 test saliva a a diagnostic tool for early detection of oral cancer
    Three groups will be compared on the basis of cytology, genes and biochemical analysis

Primary outcome measures

  • salivary cytology [Time frame: 1 year]
  • evaluation of telomere length of salivary cells [Time frame: 1 year]
  • evaluation of biochemicals of saliva [Time frame: 1 year]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • patients with oral infection

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

Pakistan · 1 center
  • Medical Research Center — Jāmshoro

Identifiers

NCT: NCT07122128 · SalivaP01 · Sal001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗