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

NCT ID: NCT04086849

Last Updated: 2023-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

450 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-30

Study Completion Date

2021-04-05

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.

Conditions

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Head and Neck Neoplasm Squamous Cell Carcinoma of Head and Neck

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Radiomic, pathomic, and clinical markers

This is a non-interventional study.

Intervention Type DIAGNOSTIC_TEST

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sunnybrook Health Sciences Centre

OTHER

Sponsor Role lead

Responsible Party

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Dr. William Tran

Radiation Therapist Clinician Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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William Tran, MRT(T), PhD

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Research Institute

Locations

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Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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087-2019

Identifier Type: -

Identifier Source: org_study_id

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