Depth of Invasion in oral cancer - Is clinical examination valid?

Recruiting

• Conditions: Malignant neoplasm of mouth, unspecified,

• Registration Number: CTRI/2019/12/022485
• Lead Sponsor: All india Institute of Medical Sciences Bhubaneswar

Brief Summary

Depth of Invasion evaluation in early oral cancer can be done clinically by palpation of the tumor and radiologically by using MRI. Clinical assessment is subjective and affected by trismus, location, subnucus fibrosis and inter observer bias. MRI is the investigation of choice. Gold standard is histopathological depth of invasion. This study is an effort to suggest that clinical assessment of depth of invasion correlated well with radiological and final histopathology. We will also look for surgical margin assessment and patter of invasion and correlate with grade of tumor, nodal status and final stage of the disease.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-12-23
• Last Update Posted: 2023-10-07

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• 1.Histopathologicalevidence of squamous cell carcinoma in oral cavity.
• 2.Patients giving consent for the planned oral surgery.
• 3.Clinically T1- T3 lesions as per AJCC 8th edition.

Exclusion Criteria

• 1.Tumors of other than squamous histology.
• 2.Patients who have receivedChemotherapy/ Radiation therapy 3.Patients having undergone excision biopsy 4.Not undergone MRI as imaging modality 5.Patients with second primary tumors.
• 6.Patients refusing to give consent.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To establish the correlation between clinical and histopathological assessment of depth of invasion in case of oral cancer.	1. Clinical Assesment Before Surgery | 2. After Imaging | 3. After Resection/Surgery | 4. After Fixation of Specimen

Secondary Outcome Measures

Name	Time	Method
To estimate the surgical margin shrinkage in formalin fixed specimen.	1. Intraoperatively
To estimate the extent of tumor shrinkage in formalin fixed specimen.
To study the correlation between pattern of invasion with grade of disease, nodal status and final stage of the disease.	1. Clinical Assesment Before Surgery

Trial Locations

Locations (1)

All india Institute of Medical Sciences; 🇮🇳 Khordha, ORISSA, India

All india Institute of Medical Sciences

🇮🇳Khordha, ORISSA, India

Mahesh Sultania

Principal investigator

9999330769

drmaheshsultania@gmail.com