Oral Squamous Cell Carcinoma (OSCC)NCT07899255
Comparison of TLC (Total Leucocyte Count), Neutrophils and Monocytes in Oral Squamous Cell Carcinoma and Pre-malignant Disorders
An observational study of Oral Squamous Cell Carcinoma (OSCC) and Premalignant Lesion, run by Dow University of Health Sciences at 1 site in Pakistan.
Trial summary
Oral squamous cell carcinoma is one of the significant public health concerns and the most prevalent malignancies affecting the head and neck region globally. The primary risk factors for this cancer include tobacco usage, alcohol consumption and increasing incidence of human papillomavirus infections (HPV). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Oral Squamous Cell Carcinoma (OSCC), Premalignant Lesion
- What is being tested?
- CBC will be required to assess the level of TLC (Total Leucocyte Count), Neutrophils and Monocytes in patient of oral squamous cell carcinoma and oral pre malignant conditions, using different stains
- Type of treatment
- Pill or oral medicine
- How many people
- 100 participants
- Where
- 1 sitePakistan
- Study dates
- 10 May 2026to 2 Jul 2027
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient coming to opd will be recruited
Who may be able to join
- Age range between 18-70 years.
- Histologically confirmed cases of oral squamous cell carcinoma and premalignant disorders.
- Patients who provided informed consent.
Who cannot join
- Active systemic infections or inflammatory conditions.
- Chemotherapy or radiotherapy treatment.
- Known hematological disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Oral squamous cell carcinoma is one of the significant public health concerns and the most prevalent malignancies affecting the head and neck region globally. The primary risk factors for this cancer include tobacco usage, alcohol consumption and increasing incidence of human papillomavirus infections (HPV). The incidence of oral squamous carcinoma has been rising among young populations and the prognosis among young and older patients remains a debated issue. However, recent studies(1) found that there is no significant difference in tumor stage or grade based on age and the premalignant disorders represent an early stage in the evolution of cancer that characterized by molecular alterations and clonal expansions that progress to malignancy. This entails that age specifically is not a determining factor in aggressiveness and treatment outcomes of Oral squamous cell carcinoma, emphasizing the need to focus on other factors that influence prognosis of this condition(2).
Premalignant disorders may involve detectable molecular alterations in blood cells and tissues, somatic mutations in key genes included DNMT3A and TET2 have been recognized in leukocytes of healthy individuals indicating a risk of future malignancy. There is a growing area of research where a comparison of hematological parameters like Total leukocytes Count (TLC), neutrophils and monocytes in OSCC patients versus those with premalignant disorders. The measurement of these blood markers provides an insight into immune response and systemic inflammation associated with malignancy progression. The evaluation and finding of Total leukocytes count, neutrophils and monocytes offered important and valuable prognostic information and also helped in distinguishing between malignant and premalignant conditions in the population. The monitoring of genetic mutations in blood cells of individuals could provide a non-invasive method to identify individuals at risk and help in better outcomes(3).
Read more
The leukocyte counts particularly neutrophils, monocytes and total leukocytes count (TLC) have been investigated for cancer progression and patient immune response. Elevated levels of these blood cells have been observed in patients with oral squamous cell carcinoma indicating systemic inflammation and alterations in immune system that are associated with malignancy, whereas in premalignant conditions alterations in these parameters in the patients indicate immune response to cellular changes with key probable to predict malignant transformation. Comparing the levels of these blood counts in oral squamous cell carcinoma patients and those with premalignant lesions provide valuable awareness and insights into immunological, inflammatory processes involved in the early stages of cancer progression(4).
There are approximately 3% of all the malignancies affecting around 270,000 people globally in annual rate. A significant amount of proportion of oral squamous cell carcinoma cases develops from premalignant disorders of the oral cavity including leukoplakia and oral submucous fibrosis, which has very high rate of malignant transformation(5). Therefore, hematological parameters would be explored as potential biomarkers for early detection of OSCC and its prognosis. Studies have revealed that quantitative changes in blood biochemistry and hematology occur during tumor initiation and progression, highlighting their potential role as the tumor markers(6).
Therefore, despite the advancement of cancer therapy the prognosis of oral squamous cell carcinoma remained poor. This is largely due to the late diagnosis of the condition, however early detection is critical for improving patient outcomes and some recent research revealed various biomarkers and hematological parameters as a potential diagnostic tool and explored that immunological and hematological changes have been observed particularly alterations in total leukocyte count, neutrophils and monocytes and these changes have been investigated as an indicators of cancer progression. This underscores the importance of studying immune and also hematological detailed profiles in Oral squamous cell carcinoma and its precursor lesions(7).
The purpose of the study is to assess and compare particular hematological parameters in individuals with premalignant conditions and those with squamous cell carcinoma. The study focus on hematological profile specifically Total leukocyte count (TLC), neutrophil count and monocyte count. By comparing these hematological markers in the patients with oral squamous cell carcinoma and the patients with pre-malignant lesions, therefore this study seeks to identify a distinct pattern that distinguishes between malignant and premalignant conditions. This comparative study aims to understand immune and inflammatory profiles of patients between two groups of study participants.
- Being tested
- CBC will be required to assess the level of TLC (Total Leucocyte Count), Neutrophils and Monocytes in patient of oral squamous cell carcinoma and oral pre malignant conditions, using different stains
- Keywords
- Oscc, OMPD
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBC will be required to assess the level of TLC (Total Leucocyte Count), Neutrophils and Monocytes in patient of oral squamous cell carcinoma and oral pre malignant conditions, using different stainsOther
CBC will be required to assess the level of TLC (Total Leucocyte Count), Neutrophils and Monocytes in patient of oral squamous cell carcinoma and oral pre malignant conditions, In addition, peripheral blood smear examination will be performed for validation purposes. Smears will be stained using the routinely employed Romanowsky stain, specifically Leishman stain. A qualified Pathologist will review the smears and confirm differential leukocyte counts under different magnification. Differential leukocyte count (DLC) will be performed using the manual counting method.
| Study group | Role | What they receive |
|---|---|---|
| Diagnosed with OSCC | Comparison of TLC (Total Leucocyte Count), Neutrophils and Monocytes Receives: Other: CBC will be required to assess the level of TLC (Total Leucocyte Count), Neutrophils and Monocytes in patient of oral squamous cell carcinoma and oral pre malignant conditions, using different stains | |
| Pre malignant conditions | Comparison of TLC (Total Leucocyte Count), Neutrophils and Monocytes Receives: Other: CBC will be required to assess the level of TLC (Total Leucocyte Count), Neutrophils and Monocytes in patient of oral squamous cell carcinoma and oral pre malignant conditions, using different stains |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the mean value of neutrophils, monocytes and total leucocyte count in oral squamous cell carcinoma and pre malignant patients.
Comparison of mean total leukocyte count, absolute neutrophil count and absolute monocyte count (cells/µL), measured by automated hematology analyzer from a 3 mL EDTA venous blood sample, between patients with oral squamous cell carcinoma and patients with oral premalignant disorders.
Measured: Single time point at enrollment (pre-operative baseline), within the 6-month data collection period.
Secondary outcomes (1)
Comparison of baseline demographic and risk factor distribution between OSCC and premalignant groups
Comparison of age (years), gender, smoking status and betel quid/areca nut use between patients with oral squamous cell carcinoma and patients with oral premalignant disorders, recorded on a structured proforma, to assess baseline comparability and potential confounding of the primary outcome.
Measured: Single time point at enrollment (pre-operative baseline), within the 6-month data collection period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start10 May 2026
- Primary completion2 Jul 2027 (estimated)
- Study completion2 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Squamous Cell Carcinoma (OSCC)Studies 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 only
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mehak Shamim, FCPS II, Principal investigator, Dow University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07899255
- Sponsor's protocol ID
- IRB4530/DUHS/Approval/2026/193
- Status last verified
- Oct 2026
- First submitted
- 28 Sep 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers. The data will be used only for the purposes of this study and will be kept confidential in accordance with institutional and ethical requirements.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of TLC (Total Leucocyte Count), Neutrophils and Monocytes in Oral Squamous Cell Carcinoma and Pre-malignant Disorders
- ClinicalTrials.gov ID
- NCT07899255
- Acronym / sponsor ID
- IRB4530/DUHS/Approval/2026/193
- Keywords
- Oscc, OMPD
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 10 May 2026 (actual)
- Primary completion
- 2 Jul 2027 (estimated)
- Study completion
- 2 Jul 2027 (estimated)
- First posted
- 27 Oct 2026 (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 squamous cell carcinoma is one of the significant public health concerns and the most prevalent malignancies affecting the head and neck region globally. The primary risk factors for this cancer include tobacco usage, alcohol consumption and increasing incidence of human papillomavirus infections (HPV). The incidence of oral squamous carcinoma has been rising among young populations and the prognosis among young and older patients remains a debated issue. However, recent studies(1) found that there is no significant difference in tumor stage or grade based on age and the premalignant disorders represent an early stage in the evolution of cancer that characterized by molecular alterations and clonal expansions that progress to malignancy. This entails that age specifically is not a determining factor in aggressiveness and treatment outcomes of Oral squamous cell carcinoma, emphasizing the need to focus on other factors that influence prognosis of this condition(2).
Premalignant disorders may involve detectable molecular alterations in blood cells and tissues, somatic mutations in key genes included DNMT3A and TET2 have been recognized in leukocytes of healthy individuals indicating a risk of future malignancy. There is a growing area of research where a comparison of hematological parameters like Total leukocytes Count (TLC), neutrophils and monocytes in OSCC patients versus those with premalignant disorders. The measurement of these blood markers provides an insight into immune response and systemic inflammation associated with malignancy progression. The evaluation and finding of Total leukocytes count, neutrophils and monocytes offered important and valuable prognostic information and also helped in distinguishing between malignant and premalignant conditions in the population. The monitoring of genetic mutations in blood cells of individuals could provide a non-invasive method to identify individuals at risk and help in better outcomes(3).
The leukocyte counts particularly neutrophils, monocytes and total leukocytes count (TLC) have been investigated for cancer progression and patient immune response. Elevated levels of these blood cells have been observed in patients with oral squamous cell carcinoma indicating systemic inflammation and alterations in immune system that are associated with malignancy, whereas in premalignant conditions alterations in these parameters in the patients indicate immune response to cellular changes with key probable to predict malignant transformation. Comparing the levels of these blood counts in oral squamous cell carcinoma patients and those with premalignant lesions provide valuable awareness and insights into immunological, inflammatory processes involved in the early stages of cancer progression(4).
There are approximately 3% of all the malignancies affecting around 270,000 people globally in annual rate. A significant amount of proportion of oral squamous cell carcinoma cases develops from premalignant disorders of the oral cavity including leukoplakia and oral submucous fibrosis, which has very high rate of malignant transformation(5). Therefore, hematological parameters would be explored as potential biomarkers for early detection of OSCC and its prognosis. Studies have revealed that quantitative changes in blood biochemistry and hematology occur during tumor initiation and progression, highlighting their potential role as the tumor markers(6).
Therefore, despite the advancement of cancer therapy the prognosis of oral squamous cell carcinoma remained poor. This is largely due to the late diagnosis of the condition, however early detection is critical for improving patient outcomes and some recent research revealed various biomarkers and hematological parameters as a potential diagnostic tool and explored that immunological and hematological changes have been observed particularly alterations in total leukocyte count, neutrophils and monocytes and these changes have been investigated as an indicators of cancer progression. This underscores the importance of studying immune and also hematological detailed profiles in Oral squamous cell carcinoma and its precursor lesions(7).
The purpose of the study is to assess and compare particular hematological parameters in individuals with premalignant conditions and those with squamous cell carcinoma. The study focus on hematological profile specifically Total leukocyte count (TLC), neutrophil count and monocyte count. By comparing these hematological markers in the patients with oral squamous cell carcinoma and the patients with pre-malignant lesions, therefore this study seeks to identify a distinct pattern that distinguishes between malignant and premalignant conditions. This comparative study aims to understand immune and inflammatory profiles of patients between two groups of study participants.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diagnosed with OSCC | – | Other: CBC will be required to assess the level of TLC (Total Leucocyte Count), Neutrophils and Monocytes in patient of oral squamous cell carcinoma and oral pre malignant conditions, using different stainsComparison of TLC (Total Leucocyte Count), Neutrophils and Monocytes |
| Pre malignant conditions | – | Other: CBC will be required to assess the level of TLC (Total Leucocyte Count), Neutrophils and Monocytes in patient of oral squamous cell carcinoma and oral pre malignant conditions, using different stainsComparison of TLC (Total Leucocyte Count), Neutrophils and Monocytes |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient coming to opd will be recruited
Key inclusion criteria (3 listed)
- Age range between 18-70 years.
- Histologically confirmed cases of oral squamous cell carcinoma and premalignant disorders.
- Patients who provided informed consent.
Key exclusion criteria (3 listed)
- Active systemic infections or inflammatory conditions.
- Chemotherapy or radiotherapy treatment.
- Known hematological disorders.
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 |
|---|---|---|
| CBC will be required to assess the level of TLC (Total Leucocyte Count), Neutrophils and Monocytes in patient of oral squamous cell carcinoma and oral pre malignant conditions, using different stainsCBC will be required to assess the level of TLC (Total Leucocyte Count), Neutrophils and Monocytes in patient of oral squamous cell carcinoma and oral pre malignant conditions, In addition, peripheral blood smear examination will be performed for validation purposes. Smears will be stained using the routinely employed Romanowsky stain, specifically Leishman stain. A qualified Pathologist will review the smears and confirm differential leukocyte counts under different magnification. Differential leukocyte count (DLC) will be performed using the manual counting method. | Other | Diagnosed with OSCC, Pre malignant conditions |
Primary outcome
To compare the mean value of neutrophils, monocytes and total leucocyte count in oral squamous cell carcinoma and pre malignant patients.
Time frame: Single time point at enrollment (pre-operative baseline), within the 6-month data collection period.
Comparison of mean total leukocyte count, absolute neutrophil count and absolute monocyte count (cells/µL), measured by automated hematology analyzer from a 3 mL EDTA venous blood sample, between patients with oral squamous cell carcinoma and patients with oral premalignant disorders.
1 secondary outcome
Comparison of baseline demographic and risk factor distribution between OSCC and premalignant groups
Time frame: Single time point at enrollment (pre-operative baseline), within the 6-month data collection period
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 27 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers. The data will be used only for the purposes of this study and will be kept confidential in accordance with institutional and ethical requirements.
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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. This study is not recruiting at the moment.
Mehak Shamim, FCPS II principal investigator
Dow University of 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 Oral Squamous Cell Carcinoma (OSCC) and Premalignant Lesion, run by Dow University of 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 3 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: under way, not looking for participants, as of the sponsor's last update on 27 Oct 2026. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the mean value of neutrophils, monocytes and total leucocyte count in oral squamous cell carcinoma and pre malignant patients. (time frame: Single time point at enrollment (pre-operative baseline), within the 6-month data collection period.). 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 27 Oct 2026.