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Completed

NCT Number: NCT04086849

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.

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Key information

Conditions

Head and Neck Neoplasm Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell Squamous Cell Carcinoma of Head and Neck

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radiomic, pathomic, and clinical markers

Diagnostic Test

This is a non-interventional study.

Primary outcomes

  1. 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

  1. Time to distant metastasis

    Time frame: Up to 60 months

    Evaluating onset of distant metastasis

  2. Time to death

    Time frame: Up to 60 months

    Evaluating time to cancer-related death

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Sep 12, 2019
Registry last updated
Apr 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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