Keywords
Oral cavity malignancies, Computed Tomography (CT), Tertiary care hospital, Histopathological correlation, Tumor thickness, Nodal staging
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Kasat P and Kashikar S. A cross-sectional study on the role of computed tomography in the evaluation of oral cavity malignancies in tertiary care hospital in central India: A study protocol [version 1; peer review: awaiting peer review]. F1000Research 2024, 13:298 (https://doi.org/10.12688/f1000research.146336.1)
NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article.
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Study Protocol
A cross-sectional study on the role of computed tomography in the evaluation of oral cavity malignancies in tertiary care hospital in central India: A study protocol
[version 1; peer review: awaiting peer review]
PUBLISHED 18 Apr 2024
OPEN PEER REVIEW
REVIEWER STATUS
This article is included in the Datta Meghe Institute of Higher Education and Research collection.
Abstract
Corresponding author:
Paschyanti Kasat
Competing interests:
No competing interests were disclosed.
Grant information:
The author(s) declared that no grants were involved in supporting this work.
Copyright:
© 2024 Kasat P and Kashikar S.
This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
How to cite: Kasat P and Kashikar S. A cross-sectional study on the role of computed tomography in the evaluation of oral cavity malignancies in tertiary care hospital in central India: A study protocol [version 1; peer review: awaiting peer review]. F1000Research 2024, 13:298 (https://doi.org/10.12688/f1000research.146336.1)
First published: 18 Apr 2024, 13:298 (https://doi.org/10.12688/f1000research.146336.1)
Latest published: 18 Apr 2024, 13:298 (https://doi.org/10.12688/f1000research.146336.1)
Introduction
Oral cavity malignancies represent a significant global health concern, contributing to substantial morbidity and mortality. Accurate staging of these malignancies is crucial for guiding treatment decisions and predicting patient outcomes. Computed Tomography (CT) has emerged as a valuable imaging modality in assessing oral cavity carcinoma, providing detailed information on tumor extent and nodal involvement. The delineation of soft tissue and bony structures and the capability to assess nodal metastases position CT as an integral tool in the preoperative evaluation of oral cavity malignancies.1
Recent advancements in CT technology, such as multi-slice scanners, have enhanced imaging resolution, enabling more precise assessments of tumor characteristics. The ability of CT to accurately determine tumor thickness and identify nodal metastases holds the potential for refining treatment strategies and optimizing patient management.2 However, the literature on the correlation between CT findings and histopathological staging in the context of oral cavity malignancies in the Central Indian population is limited.
This study aims to bridge this gap by conducting a prospective, cross-sectional investigation at the Atal Bihari Vajpayee Regional Hospital (AVBRH) in Central India. By systematically evaluating the role of CT in oral cavity malignancies and correlating its findings with histopathological staging, the study seeks to provide valuable insights that can inform clinical practice and contribute to the existing body of evidence in this field.3
The comprehensive assessment of soft tissue invasion, bony involvement, and nodal metastases using CT scans in a tertiary care setting will enhance diagnostic accuracy and aid in treatment planning and prognostication. This study is designed to address the specific needs and challenges of the Central Indian population, contributing to the development of tailored approaches for managing oral cavity malignancies in this region.
Aim
The primary aim of this cross-sectional study is to assess the accuracy of Computed Tomography (CT) in evaluating oral cavity malignancies, explicitly focusing on determining tumor thickness and nodal staging. This investigation will be conducted in a tertiary care hospital in Central India.
Objectives
1. To evaluate the extent and depth of soft tissue invasion in oral cavity malignancies using CT imaging.
2. To assess the extent and depth of bony invasion in oral cavity malignancies using CT imaging.
3. To investigate the role of CT scans in assessing nodal metastases in oral cavity malignancies.
4. To assess the correlation between radiologic extent and pathological invasion in oral cavity malignancies.
Methods
Study design: This study employs a prospective, cross-sectional design to systematically evaluate the role of Computed Tomography (CT) in the assessment of oral cavity malignancies. The comparative analysis will involve correlating CT findings with histopathological staging in a time-bound manner.
Study population: The study will include patients diagnosed with or suspected to have oral cavity carcinoma. The population will encompass individuals of all age groups and both sexes. Inclusion criteria involve patients providing informed consent for participation in the study. Exclusion criteria include patients refusing consent, those with a history of contrast reaction, patients refusing investigations, and pregnant patients.
Place of study: The study will be conducted at a tertiary care hospital in Central India, specifically the Atal Bihari Vajpayee Regional Hospital (AVBRH). This hospital is chosen for its status as a tertiary care center, ensuring access to comprehensive medical facilities and specialized expertise. The geographical focus on Central India provides relevance to the local population and healthcare context. The facilities at AVBRH will be utilized for patient recruitment, data collection, and imaging procedures.
Inclusion criteria
1. Diagnosis or suspicion of oral cavity carcinoma: Patients with a clinical diagnosis or suspicion of oral cavity carcinoma based on symptoms, clinical examination, or initial diagnostic assessments.
2. Biopsy-proven cases: Patients with biopsy-proven cases of oral cavity carcinoma provide a confirmed pathological diagnosis.
3. Age and gender: Patients of all age groups, including pediatric and geriatric populations. Inclusion without discrimination based on gender; both males and females are eligible for participation.
4. Consent for participation: Patients are willing to provide informed consent for participating in the study after a detailed explanation of the procedures and processes involved. The consent form will be explained to patients who cannot read in their language.
Exclusion criteria
1. Refusal to provide consent: Patients who refuse to provide informed consent for participation in the study.
2. History of contrast reaction: Patients with a documented history of allergic or adverse reactions to contrast agents used in imaging procedures.
3. Refusal of investigations: Patients who refuse to undergo the required investigations, including CT scans and other imaging procedures.
4. Pregnancy: Pregnant patients, considering potential risks associated with radiation exposure during CT scans.
5. Contradictory medical conditions: Patients with medical conditions or contraindications that may interfere with or contradict the study procedures or compromise patient safety.
Bias
The study faces several potential biases that need careful consideration to ensure the validity and reliability of the findings. Selection bias may arise if the participants do not accurately represent the broader population with oral cavity malignancies; randomized sampling techniques and strict adherence to inclusion and exclusion criteria will be employed to counter this. Information bias may occur due to inaccuracies in data collection, interpretation, or recording, but these will be mitigated through standardized protocols and rigorous training of study personnel. Recall bias, stemming from difficulties in accurately recalling or reporting relevant medical history, will be addressed by cross-referencing patient-reported information with medical records and employing objective measures. Observer bias in interpreting imaging results will be minimized by blinding radiologists to clinical details and using standardized criteria. Sampling bias, potentially arising from disproportionate inclusion or exclusion of specific subgroups, will be mitigated by ensuring a diverse and representative sample. Efforts to counter publication bias include transparent reporting of all results and adherence to reporting guidelines. Finally, confounding bias will be addressed through statistical methods such as multivariable analysis and, when feasible, randomization to distribute confounders across study groups evenly. These proactive measures aim to enhance the internal and external validity of the study.
Enrollment
The enrollment process for participants in this study will be conducted systematically and ethically. The study team will approach eligible individuals meeting the inclusion criteria, and a detailed explanation of the study objectives, procedures, and potential benefits and risks will be provided. Informed consent will be obtained from each participant before their inclusion in the study.
To ensure a diverse and representative sample, efforts will be made to include participants across various age groups and both genders. The recruitment process will occur at the Atal Bihari Vajpayee Regional Hospital (AVBRH), a tertiary care hospital in Central India, where patients with oral cavity malignancies receive comprehensive care.
The study team will work closely with clinicians, oncologists, and other healthcare professionals caring for patients with oral cavity carcinoma to identify potential participants. Patients diagnosed with or suspected to have oral cavity carcinoma will be informed about the study, and those willing to participate will be enrolled after providing written informed consent.
Throughout the enrollment process, confidentiality and privacy will be strictly maintained. Participants will be assured that their involvement in the study is voluntary, and they have the right to withdraw at any stage without impacting their ongoing medical care.
The enrollment phase will be conducted with diligence and sensitivity, adhering to ethical guidelines and regulatory standards. Regular monitoring will be in place to track enrollment progress and address any concerns or questions participants raise. This approach aims to build trust with participants and contribute to the overall success of the study.
Data collection
The data collection process for this study will be systematic, rigorous, and conducted in adherence to ethical principles. Various patient information and diagnostic parameters will be meticulously documented to address the study’s objectives. The following outlines the key components and procedures involved in the data collection phase:
1. Informed consent: Before any data collection activities, each participant will obtain informed consent. This process comprehensively explains the study, its objectives, potential risks, and benefits. Participants will be allowed to ask questions, and only those providing written consent will be included in the study.
2. Demographic and clinical information: Relevant demographic details, including age and gender, will be recorded for each participant. Clinical information such as presenting symptoms, medical history, and previous treatments will also be documented.
3. Imaging data: Computed Tomography (CT) scans will be performed on the enrolled participants according to the standardized protocol outlined in the study design. The imaging data, including soft tissue invasion, bony invasion, and nodal metastases, will be carefully analyzed and recorded. Radiologic tumor thickness will be measured, and imaging findings will be correlated with the histopathological results.
4. Histopathological data: Histopathological reports from biopsies or surgical specimens will be collected and analyzed. Information regarding the extent of soft tissue, bony invasion, and nodal involvement will be extracted for correlation with CT imaging findings.
5. Follow-up data: For participants undergoing further treatment or surgical interventions, followup data, including treatment outcomes, complications, and overall survival, will be collected. This longitudinal data collection aspect will contribute to a comprehensive understanding of the disease trajectory.
6. Quality control: Rigorous measures will be implemented throughout the data collection. Regular training sessions for personnel involved in data collection will ensure standardized procedures and consistency. Data accuracy and completeness will be routinely monitored, and discrepancies will be addressed promptly.
7. Confidentiality and security: All collected data will be confidential. Information will be coded to protect participant identity, and data will be stored securely in password-protected digital formats. Access to sensitive information will be restricted to authorized personnel only.
8. Compliance with regulatory standards: The data collection process will adhere to ethical guidelines, institutional review board (IRB) approvals, and relevant regulatory standards. The study team will ensure compliance with data protection laws and guidelines to safeguard participants’ rights and privacy.
Sample size
Prevalence of oral cavity malignancies = 2%.
P = 0.02% (As per reference article4)
D = estimated error (5%) = 5%
Statistical methods
The statistical analysis for this study will be conducted with the aim of providing a rigorous evaluation of the primary objectives and hypotheses. The following outlines the key statistical methods that will be employed:
1. Descriptive statistics: Descriptive statistics, including means, standard deviations, medians, and interquartile ranges, will be used to summarize demographic characteristics, clinical features, and other relevant variables of the study population.
2. Bivariate analysis: Bivariate analysis will be performed to explore associations between different variables. Chi-square tests or Fisher’s exact tests will be used for categorical variables, while t-tests or Mann-Whitney U tests will be employed for continuous variables, as appropriate.
3. Correlation analysis: Pearson or Spearman correlation coefficients will be calculated to assess the strength and direction of relationships between radiologic and histopathologic variables, such as tumor thickness, soft tissue invasion, bony invasion, and nodal involvement.
4. Multivariable analysis: Multivariable analysis, such as logistic regression or Cox proportional hazards models, will be used to control for potential confounding factors. This will help assess the independent contribution of CT imaging variables to outcomes like overall survival or treatment response.
5. Survival analysis: Kaplan-Meier survival curves will be generated to illustrate survival patterns based on relevant variables. Log-rank tests will be used to compare survival distributions between different groups.
6. Receiver Operating Characteristic (ROC) curve analysis: ROC curve analysis will be employed to assess the diagnostic performance of CT imaging parameters in predicting outcomes such as tumor thickness and nodal involvement. Sensitivity, specificity, and area under the curve (AUC) values will be calculated.
7. Subgroup analysis: Subgroup analyses will be conducted to explore variations in the relationships between CT imaging parameters and outcomes across different demographic or clinical subgroups.
8. Statistical software: Statistical analysis will be performed using SPSS version 27.0 (free alternative, R studio Version 4.3.1), applying two-tailed tests with a significance level of 0.05.
Ethical considerations
The Institutional Ethics Committee of Datta Meghe Institute of Higher Education and Research (DU) has granted its approval to the study protocol (Reference number: DMIHER (DU)/IEC/2023/760. Date:21-03-2023). Prior to commencing the study, we will obtain written informed consent from all participants, providing them with a comprehensive explanation of the study’s objectives.
Discussion
The present study addresses a critical gap in the literature by investigating the role of Computed Tomography (CT) in the evaluation of oral cavity malignancies, specifically focusing on the Central Indian population. The discussion of the findings will be contextualized within the broader landscape of oral cavity carcinoma diagnostics and treatment planning. The use of CT in oral cavity malignancies has been supported by studies demonstrating its ability to provide high-resolution imaging, allowing for detailed assessment of soft tissue invasion, bony involvement, and nodal metastases.5 Our findings will contribute to the existing evidence base, shedding light on the correlation between CT findings and histopathological staging in a specific geographical and demographic context.
One of the primary objectives of the study is to evaluate the accuracy of CT in determining tumor thickness. Tumor thickness is a critical prognostic factor in oral cavity malignancies, influencing treatment decisions and patient outcomes.6 By correlating CT-derived tumor thickness with histopathological results, our study aims to provide insights into the reliability of CT in this crucial aspect of staging.
Furthermore, the assessment of nodal metastases is a key component of oral cavity carcinoma staging, influencing treatment strategies and overall prognosis.7 Our study will explore the role of CT in accurately detecting nodal involvement, contributing to the ongoing discourse on the efficacy of imaging modalities in guiding clinical decision-making. The study’s findings may have implications for treatment planning, particularly in determining resectability and the extent of surgical intervention required. Additionally, the correlation between radiologic and histopathologic data will provide valuable information for refining imaging protocols and enhancing diagnostic accuracy in this population.
Limitations of the study include potential biases, such as selection bias and the reliance on a single imaging modality. Addressing these limitations will be crucial in interpreting the results and extrapolating findings to clinical practice. Future research avenues may involve exploring the integration of other imaging modalities or combining imaging with molecular markers to further enhance diagnostic precision.
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how to cite this article
Kasat P and Kashikar S. A cross-sectional study on the role of computed tomography in the evaluation of oral cavity malignancies in tertiary care hospital in central India: A study protocol [version 1; peer review: awaiting peer review]. F1000Research 2024, 13:298 (https://doi.org/10.12688/f1000research.146336.1)
NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article.
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