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

NCT04086849 | Completed

• 1 other identifier: 087-2019
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Time to distant metastasis

  Up to 60 months

• Time to death

  Up to 60 months

Interventions

Radiomic, pathomic, and clinical markers DIAGNOSTIC_TEST

This is a non-interventional study.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This study will enroll women and men with a pathologically-confirmed diagnosis of early-stage oral cavity or oropharyngeal squamous cell carcinoma that undergo surgery to excise the tumor.

You may qualify if:

• 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.

You may not qualify if:

• Participants who had other primary cancers prior to oral cavity or oropharyngeal cancer

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Fixed tissue samples

MeSH Terms

Conditions

Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck; Carcinoma, Squamous Cell

Interventions

Radiomics

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• William Tran, MRT(T), PhD

  Sunnybrook Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radiation Therapist Clinician Scientist

Study Record Dates

• First Submitted: September 10, 2019
• First Posted: September 12, 2019
• Study Start: July 30, 2019
• Primary Completion: March 26, 2021
• Study Completion: April 5, 2021
• Last Updated: April 11, 2023

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be available within 12 months of study completion.
• Access Criteria: Digital pathology images, anonymized clinical data, source codes, and computational methods will be deposited to open-source repositories.

Locations

CA (1)