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

NCT ID: NCT07122128

Last Updated: 2025-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-01

Study Completion Date

2026-06-30

Brief Summary

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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

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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.

Conditions

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

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Normal healthy volunteers

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

saliva a a diagnostic tool for early detection of oral cancer

Intervention Type DIAGNOSTIC_TEST

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

oral submucous fibrosis

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

saliva a a diagnostic tool for early detection of oral cancer

Intervention Type DIAGNOSTIC_TEST

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

oral cancer patients

patients with biopsy proven oral cancer

saliva a a diagnostic tool for early detection of oral cancer

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* patients with oral infection
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sindh Higher Education Commission

UNKNOWN

Sponsor Role collaborator

Liaquat University of Medical & Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Prof. Binafsha Manzoor Syed

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Binafsha Manzoor Prof. Syed, PhD

Role: PRINCIPAL_INVESTIGATOR

Liaquat University of Medical and Health Sciences

Locations

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Medical Research Center

Jāmshoro, Sinch, Pakistan

Site Status RECRUITING

Countries

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Pakistan

Central Contacts

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Binafsha Manzoor Prof, SYed, PhD

Role: CONTACT

00923332749201

Fasiha Dr Shah, PhD

Role: CONTACT

00923363019144

Facility Contacts

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Binafsha Manzoor Prof. Syed, PhD

Role: primary

00923332749201

Other Identifiers

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Sal001

Identifier Type: OTHER

Identifier Source: secondary_id

SalivaP01

Identifier Type: -

Identifier Source: org_study_id

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