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

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ClinicalTrials.gov Identifier: NCT04086849
Recruitment Status : Recruiting
First Posted : September 12, 2019
Last Update Posted : September 13, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. William Tran, Sunnybrook Health Sciences Centre

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.

Condition or disease Intervention/treatment
Head and Neck Neoplasm Squamous Cell Carcinoma of Head and Neck Diagnostic Test: Radiomic, pathomic, and clinical markers

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.

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Study Type : Observational
Estimated Enrollment : 450 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Analysis of Patterns of Recurrence in Head and Neck Cancer Using Clinicopathomic Markers
Actual Study Start Date : July 30, 2019
Estimated Primary Completion Date : December 30, 2024
Estimated Study Completion Date : June 30, 2025

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: Radiomic, pathomic, and clinical markers
    This is a non-interventional study.


Primary Outcome Measures :
  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 Outcome Measures :
  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


Biospecimen Retention:   Samples Without DNA
Fixed tissue samples


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04086849


Contacts
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Contact: William Tran, MRT(T), PhD 416-480-6100 ext 3746 william.tran@sunnybrook.ca
Contact: Kevin Higgins, MD, FRCSC 416-480-5104 kalsang.sheling@sunnybrook.ca

Locations
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Canada, Ontario
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: William Tran, MRT(T), PhD    416-480-6100 ext 3746    william.tran@sunnybrook.ca   
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Investigators
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Principal Investigator: William Tran, MRT(T), PhD Sunnybrook Research Institute

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Responsible Party: Dr. William Tran, Radiation Therapist Clinician Scientist, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT04086849     History of Changes
Other Study ID Numbers: 087-2019
First Posted: September 12, 2019    Key Record Dates
Last Update Posted: September 13, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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).
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. William Tran, Sunnybrook Health Sciences Centre:
radiomics
pathomics
head and neck cancer
biomarkers
machine learning
artificial intelligence
squamous cell carcinoma
Additional relevant MeSH terms:
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Carcinoma, Squamous Cell
Head and Neck Neoplasms
Squamous Cell Carcinoma of Head and Neck
Recurrence
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Disease Attributes
Pathologic Processes