Immunohistochemical Expression of EGFR in the Patients Having Oral Squamous Cell Carcinoma

NCT06606301 | Completed DMC

• 1 other identifier: NUMS/AFPG/21/MPHIL/019
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Oral Cancer , Oral Squamous Cell Carcinoma, Oral Cavity Cancer

Keywords

Oral Squamous Cell Carcinoma, Epidermal Growth Factor Receptor, Marker, Prognosis

Outcome Measures

Primary Outcomes (1)

• Correlation of EGFR expression with tumor

  To determine the correlation of EGFR with tumor and to establish EGFR as a prognostic marker

  05 months

Secondary Outcomes (1)

• Association of EGFR expression with tumor

  05 months

Study Arms (1)

Different Grades of squamous cell carcinoma

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

Interventions

BioSB EGFR antibody DIAGNOSTIC_TEST

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.

Different Grades of squamous cell carcinoma

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Cases of surgically treated lip/oral cavity squamous cell carcinoma
• Patients of all age groups, irrespective of their gender
• Patients with a tumor located in the tongue, inferior and superior gingivae, buccal mucosa, floor of the mouth, palate, alveolus and vestibule(buccal/labial and mandible/maxilla)

You may not qualify if:

• All specimens with inadequate or poor fixation.
• All specimen of patients having received chemotherapy/radiotherapy prior to surgery
• Very scanty tissue biopsies or those with extensive tissue necrosis
• Patients not consenting to be the part of the study

Sponsors & Collaborators

• Combined Military Hospital, Pakistan: lead
• National University of Medical Sciences, Pakistan: collaborator

Study Sites (1)

Armed Forces Institute of Pathology, Combined Military Hospital

Rawalpindi, Punjab Province, 46000, Pakistan

Location

Related Publications (3)

• Hashmi AA, Bukhari U, Aslam M, Joiya RS, Kumar R, Malik UA, Zia S, Khan AR, Saleem M, Irfan M. Clinicopathological Parameters and Biomarker Profile in a Cohort of Patients With Head and Neck Squamous Cell Carcinoma (HNSCC). Cureus. 2023 Jul 15;15(7):e41941. doi: 10.7759/cureus.41941. eCollection 2023 Jul.

  PMID: 37588336 BACKGROUND

• Gupta S, Pandey P, Verma S, Verma A. p16, p53 and EGFR expression in head and neck squamous cell carcinoma and their correlation with clinicopathological parameters. J Cancer Res Ther. 2024 Apr 1;20(3):881-887. doi: 10.4103/jcrt.JCRT_201_20. Epub 2024 Jun 27.

  PMID: 39023595 BACKGROUND

• Bernardes VF, Gleber-Netto FO, Sousa SF, Rocha RM, Aguiar MC. EGFR status in oral squamous cell carcinoma: comparing immunohistochemistry, FISH and CISH detection in a case series study. BMJ Open. 2013 Jan 28;3(1):e002077. doi: 10.1136/bmjopen-2012-002077.

  PMID: 23358562 BACKGROUND

MeSH Terms

Conditions

Mouth Neoplasms; Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Mariya Farooq, BDS

  AFIP, Combined Military Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.Phil.Trainee in Oral and Maxillofacial Pathology, Principal Investigator

Study Record Dates

• First Submitted: September 18, 2024
• First Posted: September 23, 2024
• Study Start: August 26, 2023
• Primary Completion: November 30, 2023
• Study Completion: December 28, 2023
• Last Updated: September 24, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)