Oral CancerNCT05927220
WORST PATTERN OF INVASION IN ORAL SQUAMOUS CELL CARCINOMA
An observational study of Oral Cancer and Oral Cavity Cancer, run by Armed Forces Institute of Pathology Rawalpindi at 1 site in Pakistan.
Trial summary
Cancer of the oral mucosa, also known as oral squamous cell carcinoma (OSCC), occurs as an ulceroproliferative lesion that can develop at any site in the mouth, from the lips to oropharynx. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Cancer, Oral Cavity Cancer, Oral Squamous Cell Carcinoma
- What is being tested?
- Biopsy Specimens Histopathology
- How many people
- 81 participants
- Where
- 1 sitePakistan
- Study dates
- 3 Jul 2023to 30 Nov 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All the recent biopsy specimens of OSCC with neck dissection submitted to AFIP will be selected through convenience sampling method.
Who may be able to join
- All OSCC patients who underwent neck dissections
- Patients from all age groups and both genders
Who cannot join
- All specimens with poor fixation
- All specimens of patients having received chemotherapy and/or radiotherapy prior to the surgery
- Patients not consenting to be the part of study
Trial locations and contacts
1 site in 1 country.
Maj. Umair Aslam Shahzad, MBBS, FCPS, Dip RCPath UK contact
Pakistan1 site, 1 recruiting
- Recruiting
Armed Forces Institute of Pathology
Rawalpindi, Punjab Province, 46000
Manahil Rahat, BDS, +923335681022, manahil.khan191993@gmail.com
Maj. Umair Aslam Shahzad, MBBS, FCPS, Dip RCPath UK, umair.niazi27@gmail.com
About this study
Official title: WORST PATTERN OF INVASION IN ORAL SQUAMOUS CELL CARCINOMA: AN INDEPENDENT PROGNOSTIC INDICATOR
Cancer of the oral mucosa, also known as oral squamous cell carcinoma (OSCC), occurs as an ulceroproliferative lesion that can develop at any site in the mouth, from the lips to oropharynx. OSCC (Oral squamous cell carcinoma) is a biologically aggressive tumor and this has piqued interest in research into several prognostic histopathological indicators during the past few decades. The AJCC 8th edition TNM staging system incorporates histopathological factors including depth of invasion (DOI) that affect patient outcomes. Numerous studies have linked a poor prognosis and increased locoregional failure with certain \"patterns of invasion\" (POI) in OSCC. However, this factor is not utilized for treatment decision making and for outcome assessment.
The management and prognosis of oral squamous cell carcinoma (OSCC) depends on tumor stage, differentiation, perineural and lymphovascular invasion, depth of invasion, margin status, lymph node (LN) metastasis and extranodal extension. We will evaluate the relationship of these histopathological parameters with cohesive and non cohesive worst patterns of invasion (WPOI) in OSCC. The purpose of this cross-sectional study is to determine that presence of non-cohesive WPOI is associated with advanced T stage, poor differentiation, PNI, greater depth of invasion, and higher chances of nodal metastasis. WPOI is associated with poor DFS (disease free survival), treatment intensification in early stage disease with non-cohesive WPOI may improve survival.
Therefore, it should also be included in routine reporting protocol for OSCC to aid in describing the aggressive behaviour of disease.
Read the detailed description
Oral cancer is one of the most often diagnosed types of the disease in Pakistan (Globocan, 2020 Pakistan). Squamous cell carcinomas account for over 90% of oral cancers (Anwar et al., 2020) . Several indicators point to a poor prognosis for OSCC, such as advanced tumor stage, higher tumor grade, extra capsular extension, nodal metastases, greater depth of invasion, lymphovascular invasion, poor differentiation, positive surgical margins, and perineural invasion have all been shown to be related with poor prognosis of patients with OSCC (Khan et al., 2023) . These factors have been rarely evaluated in Pakistani population.
Although there have been significant advances in the management of other types of cancer, OSCC still has few therapeutic options. The overall five-year survival rate for this illness remains about 50% despite substantial study over the preceding few decades.
(Chen et al., 2018) . Surgery followed by adjuvant radiation therapy and/or chemotherapy is still considered the gold standard for treating cancer. Early stage oral tongue carcinomas that are 4 mm or deeper at diagnosis, or that have a development pattern of small cell islands or satellites, should be treated as high-risk tumors requiring a multimodal approach (Lakhera et al., 2023) . Previous research into the significance of tumor budding in oral cavity malignancies has linked it to increased rates of lymph node metastases, relapse, and poor overall survival.
(Almangush et al., 2018) .Similar is seen with tumours that have greater depth of invasion. (Moeckelmann N, 2018)
The invasive tumor front is the transition zone between the tumors and the surrounding stroma. The infiltration pattern of tumors at the tumor front has been studied in a few prior investigations. (Chatterjee et al., 2019) This needs separate attention now as The College of American Pathologists now includes the reporting of oral cavity cancers based on the patterns of tumor invasion but they are not well-established prognostic variables.
(Seethala et al., 2021) This is due to the dearth of published research on the topic of invasive tumors. (Arora et al., 2017) . Despite its low prognostic value, the World Health
7
Organization\'s (WHO) 4th edition (2017) classification of OSCC still endorses a simple, differentiation-based histopathologic grading system that disregards important variables like tumour growth pattern and dissociation, stromal reactions (desmoplasia, local immune response), and tumor-stroma ratio. (Almangush et al., 2020) Several histological markers, easily evaluated on regular hematoxylin and eosin-stained sections, predict the outcome of OSCC. The aforementioned metrics are excellent predictors of future outcomes. These, along with WPOI, are simple and reliable prognostic indicators in early-stage OSCC that are linked to a worse prognosis. Since WPOI may aid in the individualised management of OSCC patients, it is recommended that it be evaluated in both resection and preoperative biopsy specimens as part of a standardised reporting format. (Chatterjee et al., 2019)
- Being tested
- Biopsy Specimens Histopathology
- Keywords
- prognosis, TNM staging, Oral Squamous Cell Carcinoma
- 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.
Biopsy Specimens HistopathologyDiagnostic test
paraffin-embedded blocks with sections from the tumor will be selected. Patterns of invasion will be recorded by for all cases by histopathologists
| Study group | Role | What they receive |
|---|---|---|
| cohesive (I-III) worst patterns of invasion at tumor host interface | Not described Receives: Diagnostic Test: Biopsy Specimens Histopathology | |
| non-cohesive (IV-V) worst patterns of invasion at tumor host interface | Not described Receives: Diagnostic Test: Biopsy Specimens Histopathology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of Different Histopathological Factors & Patterns of Invasion
Correlation with cohesive (I-III) and non-cohesive (IV-V) worst patterns of invasive at tumor host interface in OSCC
Measured: 03 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start3 Jul 2023 (estimated)
- Primary completion31 Aug 2023 (estimated)
- Study completion30 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Oral 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
- 81 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Armed Forces Institute of Pathology Rawalpindi
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Manahil Rahat, Armed Forces Institute of Pathology Rawalpindi
- Investigators
- Manahil Rahat, BDS, Principal investigator, AFIP Rawalpindi Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05927220
- Sponsor's protocol ID
- NUMS/AFPG/22/MPHIL/029
- Status last verified
- Jun 2023
- First submitted
- 22 Jun 2023
- Last updated
- 3 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chatterjee D, Bansal V, Malik V, Bhagat R, Punia RS, Handa U, Gupta A, Dass A. Tumor Budding and Worse Pattern of Invasion Can Predict Nodal Metastasis in Oral Cancers and Associated With Poor Survival in Early-Stage Tumors. Ear Nose Throat J. 2019 Aug;98(7):E112-E119. doi: 10.1177/0145561319848669. Epub 2019 May 9.
PubMed 31072197Mishra A, Das A, Dhal I, Shankar R, Bhavya BM, Singh N, Tripathi P, Daga D, Rai A, Gupta M, Sahu GC. Worst pattern of invasion in oral squamous cell carcinoma is an independent prognostic factor. J Oral Biol Craniofac Res. 2022 Nov-Dec;12(6):771-776. doi: 10.1016/j.jobcr.2022.08.027. Epub 2022 Sep 8.
PubMed 36159069
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WORST PATTERN OF INVASION IN ORAL SQUAMOUS CELL CARCINOMA: AN INDEPENDENT PROGNOSTIC INDICATOR
- ClinicalTrials.gov ID
- NCT05927220
- Acronym / sponsor ID
- NUMS/AFPG/22/MPHIL/029
- Keywords
- prognosis, TNM staging, Oral Squamous Cell Carcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 81 participants (estimated)
- Lead sponsor
- Armed Forces Institute of Pathology RawalpindiOther government
- Study start
- 3 Jul 2023 (estimated)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 3 Jul 2023 (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.
Cancer of the oral mucosa, also known as oral squamous cell carcinoma (OSCC), occurs as an ulceroproliferative lesion that can develop at any site in the mouth, from the lips to oropharynx. OSCC (Oral squamous cell carcinoma) is a biologically aggressive tumor and this has piqued interest in research into several prognostic histopathological indicators during the past few decades. The AJCC 8th edition TNM staging system incorporates histopathological factors including depth of invasion (DOI) that affect patient outcomes. Numerous studies have linked a poor prognosis and increased locoregional failure with certain \"patterns of invasion\" (POI) in OSCC. However, this factor is not utilized for treatment decision making and for outcome assessment.
The management and prognosis of oral squamous cell carcinoma (OSCC) depends on tumor stage, differentiation, perineural and lymphovascular invasion, depth of invasion, margin status, lymph node (LN) metastasis and extranodal extension. We will evaluate the relationship of these histopathological parameters with cohesive and non cohesive worst patterns of invasion (WPOI) in OSCC. The purpose of this cross-sectional study is to determine that presence of non-cohesive WPOI is associated with advanced T stage, poor differentiation, PNI, greater depth of invasion, and higher chances of nodal metastasis. WPOI is associated with poor DFS (disease free survival), treatment intensification in early stage disease with non-cohesive WPOI may improve survival.
Therefore, it should also be included in routine reporting protocol for OSCC to aid in describing the aggressive behaviour of disease.
Detailed description
Oral cancer is one of the most often diagnosed types of the disease in Pakistan (Globocan, 2020 Pakistan). Squamous cell carcinomas account for over 90% of oral cancers (Anwar et al., 2020) . Several indicators point to a poor prognosis for OSCC, such as advanced tumor stage, higher tumor grade, extra capsular extension, nodal metastases, greater depth of invasion, lymphovascular invasion, poor differentiation, positive surgical margins, and perineural invasion have all been shown to be related with poor prognosis of patients with OSCC (Khan et al., 2023) . These factors have been rarely evaluated in Pakistani population.
Although there have been significant advances in the management of other types of cancer, OSCC still has few therapeutic options. The overall five-year survival rate for this illness remains about 50% despite substantial study over the preceding few decades.
(Chen et al., 2018) . Surgery followed by adjuvant radiation therapy and/or chemotherapy is still considered the gold standard for treating cancer. Early stage oral tongue carcinomas that are 4 mm or deeper at diagnosis, or that have a development pattern of small cell islands or satellites, should be treated as high-risk tumors requiring a multimodal approach (Lakhera et al., 2023) . Previous research into the significance of tumor budding in oral cavity malignancies has linked it to increased rates of lymph node metastases, relapse, and poor overall survival.
(Almangush et al., 2018) .Similar is seen with tumours that have greater depth of invasion. (Moeckelmann N, 2018)
The invasive tumor front is the transition zone between the tumors and the surrounding stroma. The infiltration pattern of tumors at the tumor front has been studied in a few prior investigations. (Chatterjee et al., 2019) This needs separate attention now as The College of American Pathologists now includes the reporting of oral cavity cancers based on the patterns of tumor invasion but they are not well-established prognostic variables.
(Seethala et al., 2021) This is due to the dearth of published research on the topic of invasive tumors. (Arora et al., 2017) . Despite its low prognostic value, the World Health
7
Organization\'s (WHO) 4th edition (2017) classification of OSCC still endorses a simple, differentiation-based histopathologic grading system that disregards important variables like tumour growth pattern and dissociation, stromal reactions (desmoplasia, local immune response), and tumor-stroma ratio. (Almangush et al., 2020) Several histological markers, easily evaluated on regular hematoxylin and eosin-stained sections, predict the outcome of OSCC. The aforementioned metrics are excellent predictors of future outcomes. These, along with WPOI, are simple and reliable prognostic indicators in early-stage OSCC that are linked to a worse prognosis. Since WPOI may aid in the individualised management of OSCC patients, it is recommended that it be evaluated in both resection and preoperative biopsy specimens as part of a standardised reporting format. (Chatterjee et al., 2019)
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cohesive (I-III) worst patterns of invasion at tumor host interface | – | Diagnostic Test: Biopsy Specimens Histopathology |
| non-cohesive (IV-V) worst patterns of invasion at tumor host interface | – | Diagnostic Test: Biopsy Specimens Histopathology |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All the recent biopsy specimens of OSCC with neck dissection submitted to AFIP will be selected through convenience sampling method.
Key inclusion criteria (2 listed)
- All OSCC patients who underwent neck dissections
- Patients from all age groups and both genders
Key exclusion criteria (3 listed)
- All specimens with poor fixation
- All specimens of patients having received chemotherapy and/or radiotherapy prior to the surgery
- Patients not consenting to be the part of 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 |
|---|---|---|
| Biopsy Specimens Histopathologyparaffin-embedded blocks with sections from the tumor will be selected. Patterns of invasion will be recorded by for all cases by histopathologists | Diagnostic test | cohesive (I-III) worst patterns of invasion at tumor host interface, non-cohesive (IV-V) worst patterns of invasion at tumor host interface |
Primary outcome
Correlation of Different Histopathological Factors & Patterns of Invasion
Time frame: 03 months
Correlation with cohesive (I-III) and non-cohesive (IV-V) worst patterns of invasive at tumor host interface in OSCC
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Results publication: PubMed 31072197Chatterjee D, Bansal V, Malik V, Bhagat R, Punia RS, Handa U, Gupta A, Dass A. Tumor Budding and Worse Pattern of Invasion Can Predict Nodal Metastasis in Oral Cancers and Associated With Poor Survival in Early-Stage Tumors. Ear Nose Throat J. 2019 Aug;98(7):E112-E119. doi: 10.1177/0145561319848669. Epub 2019 May 9.
- Results publication: PubMed 36159069Mishra A, Das A, Dhal I, Shankar R, Bhavya BM, Singh N, Tripathi P, Daga D, Rai A, Gupta M, Sahu GC. Worst pattern of invasion in oral squamous cell carcinoma is an independent prognostic factor. J Oral Biol Craniofac Res. 2022 Nov-Dec;12(6):771-776. doi: 10.1016/j.jobcr.2022.08.027. Epub 2022 Sep 8.
- Globocan Cancer Observatory 2020Link provided by the sponsor.
- Oral cancer: Clinicopathological features and associated risk factors in a high risk population presenting to a major tertiary care center in PakistanLink provided by the sponsor.
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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.
Maj. Umair Aslam Shahzad, MBBS, FCPS, Dip RCPath UK contact
Manahil Rahat, BDS principal investigator
AFIP Rawalpindi Pakistan
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 and Oral Cavity Cancer, run by Armed Forces Institute of Pathology Rawalpindi 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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 3 Jul 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Manahal Rahat, BDS (+923335681022, manahil.khan191993@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of Different Histopathological Factors & Patterns of Invasion (time frame: 03 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 NCT05927220, which also lists 2 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 3 Jul 2023.