Efficacy of Oral Cancer Resection Guided by Narrow Band Imaging on Local Recurrence

Not Applicable

• Conditions: Oral Squamous Cell Carcinoma; Cancer - Head and neck

• Registration Number: ACTRN12616001071415
• Lead Sponsor: Professor Camile Farah

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-08-10
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

Patients planned for surgical management of Oral Squamous Cell Carcinoma.
>18 years of age.
Patients able to give informed consent.

Exclusion Criteria

Oral Squamous Cell Carcinoma planned for non-operative management.
<18 years of age.
Patients unable to give informed consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ocal recurrence of OSCC.<br>Measured by clinical examination and subsequent investigation should there be any clinical suspicion of recurrence.<br>Investigation for recurrence would proceed as per usual clinical practice. This includes imaging (CT scan, PET scan, MRI) and biopsy.[Measured at routine outpatient follow-up 3 and 5 years post initial surgery for Oral Squamous Cell Carcinoma. ];Disease free survival.<br>Measured by attendance/ non-attendance of participant at routine post-operative follow-up. Assessed by clinical examination, and follow-up imaging or biopsy as indicated by standard of care practices.<br>Should the patient not attend follow-up the medical record will be reviewed to determine whether the patient is alive or deceased. [Measured at routine outpatient follow-up 3 and 5 years post initial surgery for Oral Squamous Cell Carcinoma. ]

Secondary Outcome Measures

Name	Time	Method
Presence/absence of OSCC at the surgical margin.<br>- Measured by histopathological assessment of cancer at margins (‘positive’ vs. ‘negative’ margin). Margins will be designated close, involved, clear as on standard histopathological assessment.<br>- Measured by molecular profiling (using Next generation Sequencing using both exome and transcriptome panels), comparing NBI margin to WL margin and tumour.<br>[During the immediate post-operative period, over a time course of two weeks. ];Cost effectiveness of NBI procedure compared to WL procedure.<br>Financial cost of treatment for Oral Squamous Cell Carcinoma. <br>Measured in dollars saved.<br>Assessed by review of medical records and data linkage to hospital cost records. [Measured at routine outpatient follow-up 3 and 5 years post initial surgery for Oral Squamous Cell Carcinoma. ]