Oral Cancer , Oral Squamous Cell Carcinoma, Oral Cavity CancerEGFRNCT06606301
Immunohistochemical Expression of EGFR in the Patients Having Oral Squamous Cell Carcinoma
An observational study of Oral Cancer , Oral Squamous Cell Carcinoma, Oral Cavity Cancer, run by Combined Military Hospital, Pakistan at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Oral Cancer , Oral Squamous Cell Carcinoma, Oral Cavity Cancer
- What is being tested?
- BioSB EGFR antibody
- How many people
- 61 participants
- Where
- 1 sitePakistan
- Study dates
- 26 Aug 2023to 28 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Armed Forces Institute of Pathology, Combined Military Hospital
Rawalpindi, Punjab Province, 46000
About this study
Official title: Immunohistochemical Expression of EGFR in Oral Squamous Cell Carcinoma- A Cross Sectional Study
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.
Read the detailed description
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.
- Being tested
- BioSB EGFR antibody
- Keywords
- Oral Squamous Cell Carcinoma, Epidermal Growth Factor Receptor, Marker, Prognosis
- Medical subject headings
- Mouth Neoplasms, 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.
BioSB EGFR antibodyDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: BioSB EGFR antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of EGFR expression with tumor
To determine the correlation of EGFR with tumor and to establish EGFR as a prognostic marker
Measured: 05 months
Secondary outcomes (1)
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.
Measured: 05 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start26 Aug 2023
- Primary completion30 Nov 2023
- Study completion28 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Oral Cancer , Oral Squamous Cell Carcinoma, Oral Cavity CancerStudies 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Combined Military Hospital, Pakistan
- Sponsor type
- University, hospital or other
- Collaborators
- National University of Medical Sciences, Pakistan
- Responsible party
- Principal investigator, Mariya Farooq, Combined Military Hospital, Pakistan
- Investigators
- Mariya Farooq, BDS, Principal investigator, AFIP, Combined Military Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06606301
- Sponsor's protocol ID
- NUMS/AFPG/21/MPHIL/019
- Acronym
- EGFR
- Status last verified
- Sep 2024
- First submitted
- 18 Sep 2024
- Last updated
- 24 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37588336Gupta 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.
PubMed 39023595Bernardes 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.
PubMed 23358562
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunohistochemical Expression of EGFR in Oral Squamous Cell Carcinoma- A Cross Sectional Study
- ClinicalTrials.gov ID
- NCT06606301
- Acronym / sponsor ID
- EGFR / NUMS/AFPG/21/MPHIL/019
- Keywords
- Oral Squamous Cell Carcinoma, Epidermal Growth Factor Receptor, Marker, Prognosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Combined Military Hospital, PakistanUniversity, hospital or other
- Collaborators
- National University of Medical Sciences, Pakistan
- Study start
- 26 Aug 2023 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 28 Dec 2023 (actual)
- First posted
- 23 Sep 2024 (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 (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.
Detailed description
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Different Grades of squamous cell carcinoma | – | Diagnostic Test: BioSB EGFR antibodyDiagnostic 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| BioSB EGFR antibodyAppropriate 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. | Diagnostic test | Different Grades of squamous cell carcinoma |
Primary outcome
Correlation of EGFR expression with tumor
Time frame: 05 months
To determine the correlation of EGFR with tumor and to establish EGFR as a prognostic marker
1 secondary outcome
Association of EGFR expression with tumor
Time frame: 05 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2024.
- Background: PubMed 37588336Hashmi 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.
- Background: PubMed 39023595Gupta 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.
- Background: PubMed 23358562Bernardes 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.
- Individual participant dataSharing planned: No
Related trials for Oral Cancer , Oral Squamous Cell Carcinoma, Oral Cavity Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingPhase 3
Testing the Addition of Anti-Cancer Drug, Cetuximab, to Standard of Care Treatment (Pembrolizumab) for Returning or Spreading Head and Neck Cancer After Previous Treatment
Metastatic Head and Neck Squamous Cell Carcinoma, Metastatic Hypopharyngeal Squamous Cell Carcinoma
RecruitingObservational study
Head and Neck Carcinoma Clinical Research Platform for Molecular and Blood-based Biomarkers, Treatment and Outcome
Squamous Cell Carcinoma of the Oral Cavity, Squamous Cell Carcinoma of the Oropharynx
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.
Mariya Farooq, BDS principal investigator
AFIP, Combined Military Hospital
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 Cancer , Oral Squamous Cell Carcinoma, Oral Cavity Cancer, run by Combined Military Hospital, Pakistan 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 4 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: finished, as of the sponsor's last update on 24 Sep 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Correlation of EGFR expression with tumor (time frame: 05 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06606301, which also lists 3 linked publications.
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 24 Sep 2024.