An observational study in Head and Neck Neoplasm and Squamous Cell Carcinoma of Head and Neck, sponsored by Sunnybrook Health Sciences Centre. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-11.
Sponsored by Sunnybrook Health Sciences Centre · Observational
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.
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.
1,772 studies on the registry are indexed under Carcinoma, Squamous Cell; 412 are open to participants now.
This study's enrollment of 450 is above the median of 100 across 268 observational studies indexed under Carcinoma, Squamous Cell.
Browse Carcinoma, Squamous Cell studies →Sunnybrook Health Sciences Centre is the lead sponsor of 566 studies on the registry; 134 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
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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.
Exclusion Criteria:
This is a non-interventional study.
Time to locoregional recurrence
Evaluating the time until a recurrence event has occurred in the oral cavity or oropharyngeal region
Time frame: Up to 60 months
Time to distant metastasis
Evaluating onset of distant metastasis
Time frame: Up to 60 months
Time to death
Evaluating time to cancer-related death
Time frame: Up to 60 months
Plan to share: Yes — All data will be anonymized. Digital pathology images and anonymized clinical data will be deposited into the National Cancer Institute (NCI) data sharing repository, including The Cancer Imaging Archive (TCIA). Digital pathology images will also be annotated to facilitate analysis for other investigators. Computational methods, source-codes and instructions will be deposited to the open-source coding repository, GitHub (www.github.com).
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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Sunnybrook Health Sciences Centre