An observational study in Oral Cancer , Oral Squamous Cell Carcinoma, Oral Cavity Cancer, sponsored by Combined Military Hospital, Pakistan. Completed at 1 site in Pakistan. Per ClinicalTrials.gov, last updated 2024-09-24.
Sponsored by Combined Military Hospital, Pakistan · Observational
Oral squamous cell carcinoma (OSCC) is one of the top 10 most common malignancies worldwide. Oral squamous cell carcinoma forms a major health problem in many countries. The reason for the high incidence of oral cavity cancers in Pakistan, and South Asia in general, is the frequent, persistent, and prevalent use of substances classified as oral cancer risk factors. These include betel quid, areca nut, smoking, smokeless tobacco, viral infections such as EBV, HPV, poor oral hygiene (including sharp teeth and decay), ultraviolet (UV) exposure, nutrition, and genetic predisposition.
For several decades the management of OSCC consisted of surgery with or without radiotherapy or chemoradiotherapy. Associated with worse prognosis, overexpression of EGFR may lead to invasion, cellular migration, enhanced angiogenesis, decreased cell apoptosis, and increased metastatic potential. However, advances in immunotherapy have had a major impact on cancer treatment.
This study was exclusively designed to highlight the immunohistochemical detection of expression pattern of EGFR in already diagnosed cases of lip and OSCC in histopathology dept of AFIP and its correlation with the grade of the tumor. In this study, contact details of all diagnosed cases of SCC of lips and oral cavity from June to November 2023 were taken from the archives of Histopathology department. The patients were contacted for consent approval for participation. The data was collected (as per proforma attached), including demographic details, location of tumor. Blocks were retrieved, grade of tumor was identified followed by the application of EGFR marker. Patterns of expression of EGFR were evaluated and compared with grade of tumor to strengthen the correlation of this association.
Oral SCC is a type of cancer that develops from the oral epithelium and accounts for more than 90% of all oral malignancies, with a death rate of more than 140,000 cases globally. It is an invading neoplasm of epithelial origin with various stages of differentiation of squamous cells having a tendency for early and widespread metastatic spread to lymph nodes. It primarily affects individuals in their fifth to sixth decades of life who drink or smoke.
The diagnosis of OSCC requires a combined approach of clinical evaluation, radiological imaging, along with histopathological evaluation. The gold standard for diagnosing OSCC is an incisional/excisional biopsy. Histopathologically, OSCC is characterized by the existence of neoplastic epithelial cells that are invading the underlying connective tissue. The differentiation degree of neoplastic cells determines the histological grade of OSCC, which is an important prognostic factor.
Treatment of OSCC, depending on the current stage of the condition, can be surgery, chemotherapy, radiotherapy, or even a combined approach comprising all these options. Early-stage OSCC can often be cured with surgery or radiotherapy, whereas advanced-stage OSCC has been associated with a worse prognosis.
In conclusion, OSCC is a significant global health issue with an elevated mortality and morbidity in patients with head and neck cancer. Early detection and prompt treatment are crucial in improving the prognosis of OSCC. Oral pathologists and clinicians ought to be mindful of the risk factors, clinical characteristics, and screening requirements for OSCC to ensure timely and accurate diagnosis and treatment for the patients. Targeted therapy has evolved recently as an important treatment modality for cancer, and the most extensively studied pathways for targeted therapy are those related to EGFR.
In the era of personalized medicine, it has been largely accepted that cancer therapy protocols should be devised in light of tumor characteristics of loco-regional population. Previous studies has revealed that the immunohistochemical overexpression of EGFR correlates with poor prognosis. EGFR overexpression is considered an attractive target for anti-EGFR therapy in various tumors. In targeted therapy, entire focus will be on EGFR. This protein has been discovered in 90% of head and neck squamous cell carcinomas. Overexpression of EGFR has unfavorable clinical outcome, poor prognosis and low survival rates in OSCC. To make the diagnosis, clinical correlation with histopathological investigations should be prioritized. There is a strong rationale supporting EGFR-targeting in OSCC. HNSCC is often treated with anti-EGFR antibodies.
446 studies on the registry are indexed under Mouth Neoplasms; 130 are open to participants now.
This study's enrollment of 61 is below the median of 100 across 113 observational studies indexed under Mouth Neoplasms.
Browse Mouth Neoplasms studies →Combined Military Hospital, Pakistan is the lead sponsor of 15 studies on the registry; 4 are open to participants now.
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All the recent biopsy specimens of OSCC submitted to AFIP will be retrieved from the archives of Histopathology department and selected through non probability convenience sampling method.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Diagnostic test: Biopsy specimens Fresh sections from formalin fixed and paraffin embedded block with sections from the tumor will be prepared followed by Hematoxylin and Eosin staining according to the standard protocol.
Diagnostic Test: BioSB EGFR antibody
Appropriate sections from the tumor will be selected basing the choice on tumor content and viability eventually followed by EGFR application which will reveal a brown membrane positivity for the tumor. Total score for RGFR will be calculated by the histopathologists.
Correlation of EGFR expression with tumor
To determine the correlation of EGFR with tumor and to establish EGFR as a prognostic marker
Time frame: 05 months
Association of EGFR expression with tumor
The EGFR expression was checked for any association with the tumor. A p value of less than 0.05 was taken as significant.
Time frame: 05 months
Plan to share: No
Ran from Aug 2023 to primary completion in Nov 2023, 3 months.
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This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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Combined Military Hospital, Pakistan