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

Completed

• Conditions: Squamous Cell Carcinoma of Head and Neck; Head and Neck Neoplasm

• Registration Number: NCT04086849
• Lead Sponsor: Sunnybrook Health Sciences Centre

Brief Summary

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.

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 Timeline

• Study Start: 2019-07-30
• Study First Submitted: 2019-09-10
• Study First Submitted QC: 2019-09-10
• Study First Posted: 2019-09-12
• Primary Completion: 2021-03-26
• Study Completion: 2021-04-05
• Status Verified: 2022-09
• Last Update Submitted: 2023-04-10
• Last Update Posted: 2023-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 450

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to locoregional recurrence	Up to 60 months	Evaluating the time until a recurrence event has occurred in the oral cavity or oropharyngeal region

Secondary Outcome Measures

Name	Time	Method
Time to death	Up to 60 months	Evaluating time to cancer-related death
Time to distant metastasis	Up to 60 months	Evaluating onset of distant metastasis

Trial Locations

Locations (1)

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada