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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04086849

Enrollment

450

Registered

2019-09-12

Start date

2019-07-30

Completion date

2021-04-05

Last updated

2023-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

radiomics, pathomics, head and neck cancer, biomarkers, machine learning, artificial intelligence, squamous cell carcinoma

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.

Interventions

DIAGNOSTIC_TESTRadiomic, pathomic, and clinical markers

This is a non-interventional study.

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026