WORST PATTERN OF INVASION IN ORAL SQUAMOUS CELL CARCINOMA

NCT05927220 | Unknown DMC

• 1 other identifier: NUMS/AFPG/22/MPHIL/029
• Study Type: observational
• Target: 81
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Oral Cancer; Oral Cavity Cancer; Oral Squamous Cell Carcinoma

Keywords

prognosis; TNM staging; Oral Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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

  03 months

Study Arms (2)

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

Interventions

Biopsy Specimens Histopathology DIAGNOSTIC_TEST

paraffin-embedded blocks with sections from the tumor will be selected. Patterns of invasion will be recorded by for all cases by histopathologists

cohesive (I-III) worst patterns of invasion at tumor host interface; non-cohesive (IV-V) worst patterns of invasion at tumor host interface

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Armed Forces Institute of Pathology Rawalpindi: lead

Study Sites (1)

Armed Forces Institute of Pathology

Rawalpindi, Punjab Province, 46000, Pakistan

RECRUITING

Related Publications (2)

• 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.

  PMID: 31072197 RESULT

• Mishra 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.

  PMID: 36159069 RESULT

Related Links

• Globocan Cancer Observatory 2020
• Oral cancer: Clinicopathological features and associated risk factors in a high risk population presenting to a major tertiary care center in Pakistan

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

• Manahil Rahat, BDS

  AFIP Rawalpindi Pakistan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Manahal Rahat, BDS

CONTACT

+923335681022; manahil.khan191993@gmail.com

Maj. Umair Aslam Shahzad, MBBS, FCPS, Dip RCPath UK

CONTACT

umair.niazi27@gmail.com

Study Design

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

Study Record Dates

• First Submitted: June 22, 2023
• First Posted: July 3, 2023
• Study Start: July 3, 2023
• Primary Completion: August 31, 2023
• Study Completion: November 30, 2023
• Last Updated: July 3, 2023

Record last verified: 2023-06

Locations

PA (1)