Analysis of Patterns of Recurrence in Head and Neck Cancer Using Clinicopathomic Markers

Here, the investigators will develop a clinicopathomic assay from biomarkers obtained from digital pathologies of resected whole-mount oral cavity and oropharyngeal squamous cell carcinoma (OCSCC and OPSCC) specimens with the goal of administering personalized novel image-guided therapies immediately after primary surgical management in OCSCC and OPSCC patients. The primary aim is to determine the association between clinicopathomic biomarkers and LRR. The secondary aim is to develop a clinicopathomic risk score (assay) such that a decision-support tool can be used by physicians for measuring the benefit of additional therapies (i.e. conventional chemotherapy +/- radiation or administering dose-escalated chemoradiation) in the adjuvant setting to reduce LRR rates.

Study Overview

• Status: Completed
• Conditions: Squamous Cell Carcinoma of Head and Neck; Head and Neck Neoplasm
• Intervention / Treatment: Diagnostic test: Radiomic, pathomic, and clinical markers

Detailed Description

The proposed study is significant for developing personalized treatments. The proposed research will yield high rewards to patients by providing additional information to clinicians for better prognostication and potentially adapting adjuvant treatments to improve the survival of patients with OCSCC or OPSCC.

• Study Type: Observational
• Enrollment (Actual): 450

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Health Sciences Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

This study will enroll women and men with a pathologically-confirmed diagnosis of early-stage oral cavity or oropharyngeal squamous cell carcinoma that undergo surgery to excise the tumor.

Description

Inclusion Criteria:

• Participants must be men and women age 18+
• Confirmed diagnosis of oral cavity or oropharyngeal squamous cell carcinoma
• Participants must have received or will undergo surgery to excise the primary oropharyngeal tumor.

Exclusion Criteria:

• Participants who had other primary cancers prior to oral cavity or oropharyngeal cancer

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to locoregional recurrence	Evaluating the time until a recurrence event has occurred in the oral cavity or oropharyngeal region	Up to 60 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to distant metastasis	Evaluating onset of distant metastasis	Up to 60 months
Time to death	Evaluating time to cancer-related death	Up to 60 months

Collaborators and Investigators

• Sponsor: Sunnybrook Health Sciences Centre
• Investigators: Principal Investigator: William Tran, MRT(T), PhD, Sunnybrook Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2019
• Primary Completion (Actual): March 26, 2021
• Study Completion (Actual): April 5, 2021

Study Registration Dates

• First Submitted: September 10, 2019
• First Submitted That Met QC Criteria: September 10, 2019
• First Posted (Actual): September 12, 2019

Study Record Updates

• Last Update Posted (Actual): April 11, 2023
• Last Update Submitted That Met QC Criteria: April 10, 2023
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: machine learning; biomarkers; artificial intelligence; head and neck cancer; squamous cell carcinoma; radiomics; pathomics
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Disease Attributes; Neoplasms, Squamous Cell; Head and Neck Neoplasms; Recurrence; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
• Other Study ID Numbers: 087-2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All data will be anonymized. Digital pathology images and anonymized clinical data will be deposited into the National Cancer Institute (NCI) data sharing repository, including The Cancer Imaging Archive (TCIA). Digital pathology images will also be annotated to facilitate analysis for other investigators. Computational methods, source-codes and instructions will be deposited to the open-source coding repository, GitHub (www.github.com).
• IPD Sharing Time Frame: Data will be available within 12 months of study completion.
• IPD Sharing Access Criteria: Digital pathology images, anonymized clinical data, source codes, and computational methods will be deposited to open-source repositories.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No