An observational study in Oral Squamous Cell Carcinoma (OSCC) and Premalignant Lesion, sponsored by Dow University of Health Sciences. Active, not recruiting at 1 site in Pakistan. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Dow University of Health Sciences · Observational
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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.
2,019 studies on the registry are indexed under Squamous Cell Carcinoma of Head and Neck; 573 are open to participants now.
This study's enrollment of 100 is close to the median of 100 across 237 observational studies indexed under Squamous Cell Carcinoma of Head and Neck.
Browse Squamous Cell Carcinoma of Head and Neck studies →Dow University of Health Sciences is the lead sponsor of 179 studies on the registry; 34 are open to participants now.
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Exclusion Criteria:
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The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Comparison of TLC (Total Leucocyte Count), Neutrophils and Monocytes
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
Comparison of TLC (Total Leucocyte Count), Neutrophils and Monocytes
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
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.
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.
Time frame: Single time point at enrollment (pre-operative baseline), within the 6-month data collection period.
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.
Time frame: Single time point at enrollment (pre-operative baseline), within the 6-month data collection period
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: 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.
Started May 2026 (actual). Primary completion is estimated for Jul 2027, 13 months after the start.
Of 108 non-industry observational studies under Squamous Cell Carcinoma of Head and Neck, half reached primary completion within 81 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 132. This study's planned 13 months is below that.
Counting every sponsor, half of 118 studies reached it within 81 months; a quarter within 29 and three quarters within 132.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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