The Study Focuses on the Saliva as Potential Source of Early Detection of Oral CancerSalNCT07122128
EVALUATION OF SALIVA AS LIQUID BIOPSY FOR EARLY DETECTION OF ORAL CANCER IN PATIENTS WITH ORAL-SUBMUCOUS FIBROSIS (OSMF)
An observational study of The Study Focuses on the Saliva as Potential Source of Early Detection of Oral Cancer, run by Liaquat University of Medical & Health Sciences at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- The Study Focuses on the Saliva as Potential Source of Early Detection of Oral Cancer
- What is being tested?
- saliva a a diagnostic tool for early detection of oral cancer
- Type of treatment
- Pill or oral medicine
- How many people
- 1,000 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jun 2021to 30 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study 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.
Who may be able to join
- healthy volunteers
- patients with oral submucous fibrosis
- patients with biopsy proven oral cancer
Who cannot join
- patients with oral infection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Medical Research Center
Jāmshoro, Sinch
Binafsha Manzoor Prof. Syed, PhD, 00923332749201, binafsha.syed@lumhs.edu.pk
About this study
Official title: Saliva as Early Detection Tool for Oral Cancer
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.
Read the 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.
- Being tested
- saliva a a diagnostic tool for early detection of oral cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
saliva a a diagnostic tool for early detection of oral cancerDiagnostic test
Three groups will be compared on the basis of cytology, genes and biochemical analysis
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: saliva a a diagnostic tool for early detection of oral cancer | |
| oral submucous fibrosis | Patients with oral submucous fibrosis both with and without limited mouth opening Receives: Diagnostic Test: saliva a a diagnostic tool for early detection of oral cancer | |
| oral cancer patients | patients with biopsy proven oral cancer Receives: Diagnostic Test: saliva a a diagnostic tool for early detection of oral cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
salivary cytology
A method will be developed for evaluation of detection of oral cancer
Measured: 1 year
evaluation of telomere length of salivary cells
Telomere length will be evaluation in the saliva of three groups
Measured: 1 year
evaluation of biochemicals of saliva
saliva of three groups will be compared on the basis of salivary enzymes
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study start1 Jun 2021
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Study Focuses on the Saliva as Potential Source of Early Detection of Oral CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liaquat University of Medical & Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Sindh Higher Education Commission
- Responsible party
- Principal investigator, Prof. Binafsha Manzoor Syed, Liaquat University of Medical & Health Sciences
- Investigators
- Binafsha Manzoor Prof. Syed, PhD, Principal investigator, Liaquat University of Medical and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07122128
- Sponsor's protocol ID
- SalivaP01
- Other IDs
- Sal001
- Acronym
- Sal
- Status last verified
- Aug 2025
- First submitted
- 7 Aug 2025
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD includes: Group, age, gender, smoking status, oral hygiene status, saliva collection date, salivary cytology parameters, telomere length, p53 status
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Saliva as Early Detection Tool for Oral Cancer
- ClinicalTrials.gov ID
- NCT07122128
- Acronym / sponsor ID
- Sal / SalivaP01
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Liaquat University of Medical & Health SciencesUniversity, hospital or other
- Collaborators
- Sindh Higher Education Commission
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 14 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal healthy volunteers | – | Diagnostic Test: saliva a a diagnostic tool for early detection of oral canceroral examination will be done, those without any oral infection, oral submucous fibrosis or cancer will be included in health volunteer group |
| oral submucous fibrosis | – | Diagnostic Test: saliva a a diagnostic tool for early detection of oral cancerPatients with oral submucous fibrosis both with and without limited mouth opening |
| oral cancer patients | – | Diagnostic Test: saliva a a diagnostic tool for early detection of oral cancerpatients with biopsy proven oral cancer |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study 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.
Key inclusion criteria (3 listed)
- healthy volunteers
- patients with oral submucous fibrosis
- patients with biopsy proven oral cancer
Key exclusion criteria (1 listed)
- patients with oral infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| saliva a a diagnostic tool for early detection of oral cancerThree groups will be compared on the basis of cytology, genes and biochemical analysis | Diagnostic test | Normal healthy volunteers, oral cancer patients, oral submucous fibrosis |
Primary outcome
salivary cytology
Time frame: 1 year
A method will be developed for evaluation of detection of oral cancer
evaluation of telomere length of salivary cells
Time frame: 1 year
Telomere length will be evaluation in the saliva of three groups
evaluation of biochemicals of saliva
Time frame: 1 year
saliva of three groups will be compared on the basis of salivary enzymes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Individual participant dataSharing planned: No. IPD includes: Group, age, gender, smoking status, oral hygiene status, saliva collection date, salivary cytology parameters, telomere length, p53 status
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Binafsha Manzoor Prof. Syed, PhD principal investigator
Liaquat University of Medical and Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of The Study Focuses on the Saliva as Potential Source of Early Detection of Oral Cancer, run by Liaquat University of Medical & Health Sciences at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Binafsha Manzoor Prof, SYed, PhD (00923332749201, binafsha.syed@lumhs.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
salivary cytology (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.