WORST PATTERN OF INVASION IN ORAL SQUAMOUS CELL CARCINOMA

June 22, 2023 updated by: Manahil Rahat, Armed Forces Institute of Pathology Rawalpindi

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

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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 Type

Observational

Enrollment (Estimated)

81

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

All the recent biopsy specimens of OSCC with neck dissection submitted to AFIP will be selected through convenience sampling method.

Description

Inclusion Criteria:

  • All OSCC patients who underwent neck dissections
  • Patients from all age groups and both genders

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
cohesive (I-III) worst patterns of invasion at tumor host interface
Diagnostic test: Biopsy Specimens Histopathology
paraffin-embedded blocks with sections from the tumor will be selected. Patterns of invasion will be recorded by for all cases by histopathologists
non-cohesive (IV-V) worst patterns of invasion at tumor host interface
Diagnostic test: Biopsy Specimens Histopathology
paraffin-embedded blocks with sections from the tumor will be selected. Patterns of invasion will be recorded by for all cases by histopathologists

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
03 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Armed Forces Institute of Pathology Rawalpindi

Investigators

  • Principal Investigator: Manahil Rahat, BDS, AFIP Rawalpindi Pakistan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 3, 2023

Primary Completion (Estimated)

August 31, 2023

Study Completion (Estimated)

November 30, 2023

Study Registration Dates

First Submitted

June 22, 2023

First Submitted That Met QC Criteria

June 22, 2023

First Posted (Actual)

July 3, 2023

Study Record Updates

Last Update Posted (Actual)

July 3, 2023

Last Update Submitted That Met QC Criteria

June 22, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NUMS/AFPG/22/MPHIL/029

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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