Analysis of Patterns of Recurrence in Head and Neck Cancer Using Clinicopathomic Markers
Overview
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 450
- Locations
- 1
- Primary Endpoint
- Time to locoregional recurrence
Overview
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Time to locoregional recurrence
Time Frame: Up to 60 months
Evaluating the time until a recurrence event has occurred in the oral cavity or oropharyngeal region
Secondary Outcomes
- Time to death(Up to 60 months)
- Time to distant metastasis(Up to 60 months)
Investigators
Dr. William Tran
Radiation Therapist Clinician Scientist
Sunnybrook Health Sciences Centre