Analysis of Patterns of Recurrence in Head and Neck Cance... | NCT04086849

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

NCT04086849

Sponsor

Sunnybrook Health Sciences Centre

Status

Completed

Last Update Posted

Apr 11, 2023Actual

Enrollment

450Actual

Phase

Not provided

Conditions

Head and Neck Neoplasm
Squamous Cell Carcinoma of Head and Neck

Interventions

Radiomic, pathomic, and clinical markers

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 30, 2019Actual

Primary Completion Date

Mar 26, 2021Actual

Completion Date

Apr 5, 2021Actual

First Submitted Date

Sep 10, 2019

First Submission Date that Met QC Criteria

Sep 10, 2019

First Posted Date

Sep 12, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 10, 2023

Last Update Posted Date

Apr 11, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. William Tran, Radiation Therapist Clinician Scientist, Sunnybrook Health Sciences CentrePrincipal Investigator

Lead Sponsor

Sunnybrook Health Sciences CentreOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

450Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Radiomic, pathomic, and clinical markers	Diagnostic Test	This is a non-interventional study.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
William Tran, MRT(T), PhD	Sunnybrook Research Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sunnybrook Health Sciences Centre		Toronto	Ontario	M4N 3M5	Canada

IPD Sharing Statement Module

Plan to Share IPD

Yes

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).

Types

Not provided

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.

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006258	Head and Neck Neoplasms
D000077195	Squamous Cell Carcinoma of Head and Neck
D002294	Carcinoma, Squamous Cell

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000097188	Radiomics

Ancestor Terms

ID	Term
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided