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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Head and Neck Neoplasm, Squamous Cell Carcinoma of Head and Neck

Intervention / Treatment
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* Diagnostic Test: Radiomic, pathomic, and clinical markers


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Radiomic, pathomic, and clinical markers|This is a non-interventional study.|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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radiomics, pathomics, head and neck cancer, biomarkers, machine learning, artificial intelligence, squamous cell carcinoma