Predictability of Recurrence using Immunohistochemistry to delineate Surgical Margins in mucosal Head and Neck Squamous Cell Carcinoma (PRISM-HNSCC)

study protocol for a prospective, observational and bilateral study in Australia and India

Sheela Joseph, Rajinikanth Janakiraman, Geeta Chacko, Rama Jayaraj, Mahiban Thomas, Meera Thomas, Sramana Mukhopadhyay

Research output: Contribution to journalArticleResearchpeer-review

4 Downloads (Pure)

Abstract

Objectives: Treatment failure and poor 5-year survival in mucosal head and neck squamous cell carcinoma (HNSCC) has remained unchanged for decades mainly due to advanced stage of presentation and high rates of recurrence. Incomplete surgical removal of the tumour, attributed to lack of reliable methods to delineate the surgical margins, is a major cause of disease recurrence. The predictability of recurrence using immunohistochemistry (IHC) to delineate surgical margins (PRISM) in mucosal HNSCC study aims to redefine margin status by identifying the true extent of the tumour at the molecular level by performing IHC with molecular markers, eukaryotic initiation factor, eIF4Eand tumour suppressor gene, p53, on the surgical margins and test the use of Lugol's iodine and fluorescence visualisation prior to the wide local excision. This article describes the study protocol at its pre - results stage.

Methods and analysis: PRISM-HNSCC is a bilateral observational research being conducted in Darwin, Australia and Vellore, India. Individuals diagnosed with HNSCC will undergo the routine wide local excision of the tumour followed by histopathological assessment. Tumours with clear surgical margins that satisfy the exclusion criteria will be selected for further staining of the margins with eIF4E and p53 antibodies. Results of IHC staining will be correlated with recurrences in an attempt to predict the risk of disease recurrence. Patients in Darwin will undergo intraoperative staining of the lesion with Lugol's iodine and fluorescence visualisation to delineate the excision margins while patients in Vellore will not undertake these tests. The outcomes will be analysed.

Ethics and dissemination: The PRISM-HNSCC study was approved by the institutional ethics committees in Darwin (Human Research Ethics Committee 13-2036) and Vellore (Institutional Review Board Min. no. 8967). Outcomes will be disseminated through publications in academic journals and presentations at educational meetings and conferences. It will be presented as dissertation at the Charles Darwin University. We will communicate the study results to both participating sites. Participating sites will communicate results with patients who have indicated an interest in knowing the results.

Trial registration number: Australian New Zealand Clinical Trials Registry (ACTRN12616000715471).

Original languageEnglish
Article numbere014824
Pages (from-to)1-7
Number of pages7
JournalBMJ Open
Volume7
Issue number10
DOIs
Publication statusPublished - 1 Oct 2017

Fingerprint

Observational Studies
India
Immunohistochemistry
Recurrence
Research Ethics Committees
Staining and Labeling
Neoplasms
Fluorescence
Eukaryotic Initiation Factors
Ethics Committees
Tumor Suppressor Genes
Treatment Failure
New Zealand
Ethics
Registries
Publications
Carcinoma, squamous cell of head and neck
Margins of Excision
Clinical Trials
Survival

Cite this

Joseph, Sheela ; Janakiraman, Rajinikanth ; Chacko, Geeta ; Jayaraj, Rama ; Thomas, Mahiban ; Thomas, Meera ; Mukhopadhyay, Sramana. / Predictability of Recurrence using Immunohistochemistry to delineate Surgical Margins in mucosal Head and Neck Squamous Cell Carcinoma (PRISM-HNSCC) : study protocol for a prospective, observational and bilateral study in Australia and India. In: BMJ Open. 2017 ; Vol. 7, No. 10. pp. 1-7.
@article{1eb9dfb042ed4238805bca511b55c15f,
title = "Predictability of Recurrence using Immunohistochemistry to delineate Surgical Margins in mucosal Head and Neck Squamous Cell Carcinoma (PRISM-HNSCC): study protocol for a prospective, observational and bilateral study in Australia and India",
abstract = "Objectives: Treatment failure and poor 5-year survival in mucosal head and neck squamous cell carcinoma (HNSCC) has remained unchanged for decades mainly due to advanced stage of presentation and high rates of recurrence. Incomplete surgical removal of the tumour, attributed to lack of reliable methods to delineate the surgical margins, is a major cause of disease recurrence. The predictability of recurrence using immunohistochemistry (IHC) to delineate surgical margins (PRISM) in mucosal HNSCC study aims to redefine margin status by identifying the true extent of the tumour at the molecular level by performing IHC with molecular markers, eukaryotic initiation factor, eIF4Eand tumour suppressor gene, p53, on the surgical margins and test the use of Lugol's iodine and fluorescence visualisation prior to the wide local excision. This article describes the study protocol at its pre - results stage. Methods and analysis: PRISM-HNSCC is a bilateral observational research being conducted in Darwin, Australia and Vellore, India. Individuals diagnosed with HNSCC will undergo the routine wide local excision of the tumour followed by histopathological assessment. Tumours with clear surgical margins that satisfy the exclusion criteria will be selected for further staining of the margins with eIF4E and p53 antibodies. Results of IHC staining will be correlated with recurrences in an attempt to predict the risk of disease recurrence. Patients in Darwin will undergo intraoperative staining of the lesion with Lugol's iodine and fluorescence visualisation to delineate the excision margins while patients in Vellore will not undertake these tests. The outcomes will be analysed. Ethics and dissemination: The PRISM-HNSCC study was approved by the institutional ethics committees in Darwin (Human Research Ethics Committee 13-2036) and Vellore (Institutional Review Board Min. no. 8967). Outcomes will be disseminated through publications in academic journals and presentations at educational meetings and conferences. It will be presented as dissertation at the Charles Darwin University. We will communicate the study results to both participating sites. Participating sites will communicate results with patients who have indicated an interest in knowing the results. Trial registration number: Australian New Zealand Clinical Trials Registry (ACTRN12616000715471).",
keywords = "head and neck squamous cell carcinoma, immunohistochemistry, p53, surgical margins",
author = "Sheela Joseph and Rajinikanth Janakiraman and Geeta Chacko and Rama Jayaraj and Mahiban Thomas and Meera Thomas and Sramana Mukhopadhyay",
year = "2017",
month = "10",
day = "1",
doi = "10.1136/bmjopen-2016-014824",
language = "English",
volume = "7",
pages = "1--7",
journal = "BMJ Open",
issn = "2044-6055",
publisher = "British Medical Journal Publishing Group (BMJ Publishing)",
number = "10",

}

Predictability of Recurrence using Immunohistochemistry to delineate Surgical Margins in mucosal Head and Neck Squamous Cell Carcinoma (PRISM-HNSCC) : study protocol for a prospective, observational and bilateral study in Australia and India. / Joseph, Sheela; Janakiraman, Rajinikanth; Chacko, Geeta; Jayaraj, Rama; Thomas, Mahiban; Thomas, Meera; Mukhopadhyay, Sramana.

In: BMJ Open, Vol. 7, No. 10, e014824, 01.10.2017, p. 1-7.

Research output: Contribution to journalArticleResearchpeer-review

TY - JOUR

T1 - Predictability of Recurrence using Immunohistochemistry to delineate Surgical Margins in mucosal Head and Neck Squamous Cell Carcinoma (PRISM-HNSCC)

T2 - study protocol for a prospective, observational and bilateral study in Australia and India

AU - Joseph, Sheela

AU - Janakiraman, Rajinikanth

AU - Chacko, Geeta

AU - Jayaraj, Rama

AU - Thomas, Mahiban

AU - Thomas, Meera

AU - Mukhopadhyay, Sramana

PY - 2017/10/1

Y1 - 2017/10/1

N2 - Objectives: Treatment failure and poor 5-year survival in mucosal head and neck squamous cell carcinoma (HNSCC) has remained unchanged for decades mainly due to advanced stage of presentation and high rates of recurrence. Incomplete surgical removal of the tumour, attributed to lack of reliable methods to delineate the surgical margins, is a major cause of disease recurrence. The predictability of recurrence using immunohistochemistry (IHC) to delineate surgical margins (PRISM) in mucosal HNSCC study aims to redefine margin status by identifying the true extent of the tumour at the molecular level by performing IHC with molecular markers, eukaryotic initiation factor, eIF4Eand tumour suppressor gene, p53, on the surgical margins and test the use of Lugol's iodine and fluorescence visualisation prior to the wide local excision. This article describes the study protocol at its pre - results stage. Methods and analysis: PRISM-HNSCC is a bilateral observational research being conducted in Darwin, Australia and Vellore, India. Individuals diagnosed with HNSCC will undergo the routine wide local excision of the tumour followed by histopathological assessment. Tumours with clear surgical margins that satisfy the exclusion criteria will be selected for further staining of the margins with eIF4E and p53 antibodies. Results of IHC staining will be correlated with recurrences in an attempt to predict the risk of disease recurrence. Patients in Darwin will undergo intraoperative staining of the lesion with Lugol's iodine and fluorescence visualisation to delineate the excision margins while patients in Vellore will not undertake these tests. The outcomes will be analysed. Ethics and dissemination: The PRISM-HNSCC study was approved by the institutional ethics committees in Darwin (Human Research Ethics Committee 13-2036) and Vellore (Institutional Review Board Min. no. 8967). Outcomes will be disseminated through publications in academic journals and presentations at educational meetings and conferences. It will be presented as dissertation at the Charles Darwin University. We will communicate the study results to both participating sites. Participating sites will communicate results with patients who have indicated an interest in knowing the results. Trial registration number: Australian New Zealand Clinical Trials Registry (ACTRN12616000715471).

AB - Objectives: Treatment failure and poor 5-year survival in mucosal head and neck squamous cell carcinoma (HNSCC) has remained unchanged for decades mainly due to advanced stage of presentation and high rates of recurrence. Incomplete surgical removal of the tumour, attributed to lack of reliable methods to delineate the surgical margins, is a major cause of disease recurrence. The predictability of recurrence using immunohistochemistry (IHC) to delineate surgical margins (PRISM) in mucosal HNSCC study aims to redefine margin status by identifying the true extent of the tumour at the molecular level by performing IHC with molecular markers, eukaryotic initiation factor, eIF4Eand tumour suppressor gene, p53, on the surgical margins and test the use of Lugol's iodine and fluorescence visualisation prior to the wide local excision. This article describes the study protocol at its pre - results stage. Methods and analysis: PRISM-HNSCC is a bilateral observational research being conducted in Darwin, Australia and Vellore, India. Individuals diagnosed with HNSCC will undergo the routine wide local excision of the tumour followed by histopathological assessment. Tumours with clear surgical margins that satisfy the exclusion criteria will be selected for further staining of the margins with eIF4E and p53 antibodies. Results of IHC staining will be correlated with recurrences in an attempt to predict the risk of disease recurrence. Patients in Darwin will undergo intraoperative staining of the lesion with Lugol's iodine and fluorescence visualisation to delineate the excision margins while patients in Vellore will not undertake these tests. The outcomes will be analysed. Ethics and dissemination: The PRISM-HNSCC study was approved by the institutional ethics committees in Darwin (Human Research Ethics Committee 13-2036) and Vellore (Institutional Review Board Min. no. 8967). Outcomes will be disseminated through publications in academic journals and presentations at educational meetings and conferences. It will be presented as dissertation at the Charles Darwin University. We will communicate the study results to both participating sites. Participating sites will communicate results with patients who have indicated an interest in knowing the results. Trial registration number: Australian New Zealand Clinical Trials Registry (ACTRN12616000715471).

KW - head and neck squamous cell carcinoma

KW - immunohistochemistry

KW - p53

KW - surgical margins

UR - http://www.scopus.com/inward/record.url?scp=85031745967&partnerID=8YFLogxK

U2 - 10.1136/bmjopen-2016-014824

DO - 10.1136/bmjopen-2016-014824

M3 - Article

VL - 7

SP - 1

EP - 7

JO - BMJ Open

JF - BMJ Open

SN - 2044-6055

IS - 10

M1 - e014824

ER -