Head and Neck NeoplasmNCT04086849
Analysis of Patterns of Recurrence in Head and Neck Cancer Using Clinicopathomic Markers
An observational study of Head and Neck Neoplasm and Squamous Cell Carcinoma of Head and Neck, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Neoplasm, Squamous Cell Carcinoma of Head and Neck
- What is being tested?
- Radiomic, pathomic, and clinical markers
- How many people
- 450 participants
- Where
- 1 siteCanada
- Study dates
- 30 Jul 2019to 5 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older 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.
Who may be able to join
- 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.
Who cannot join
- Participants who had other primary cancers prior to oral cavity or oropharyngeal cancer
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Radiomic, pathomic, and clinical markers
- Keywords
- radiomics, pathomics, head and neck cancer, biomarkers, machine learning, artificial intelligence, squamous cell carcinoma
- Medical subject headings
- Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiomic, pathomic, and clinical markersDiagnostic test
This is a non-interventional study.
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to locoregional recurrence
Evaluating the time until a recurrence event has occurred in the oral cavity or oropharyngeal region
Measured: Up to 60 months
Secondary outcomes (2)
Time to distant metastasis
Evaluating onset of distant metastasis
Measured: Up to 60 months
Time to death
Evaluating time to cancer-related death
Measured: Up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2019
- Study start30 Jul 2019
- Primary completion26 Mar 2021
- Study completion5 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck NeoplasmStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. William Tran, Sunnybrook Health Sciences Centre
- Investigators
- William Tran, MRT(T), PhD, Principal investigator, Sunnybrook Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04086849
- Sponsor's protocol ID
- 087-2019
- Status last verified
- Sep 2022
- First submitted
- 10 Sep 2019
- Last updated
- 11 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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).
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Patterns of Recurrence in Head and Neck Cancer Using Clinicopathomic Markers
- ClinicalTrials.gov ID
- NCT04086849
- Acronym / sponsor ID
- 087-2019
- Keywords
- radiomics, pathomics, head and neck cancer, biomarkers, machine learning, artificial intelligence, squamous cell carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 30 Jul 2019 (actual)
- Primary completion
- 26 Mar 2021 (actual)
- Study completion
- 5 Apr 2021 (actual)
- First posted
- 12 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Participants who had other primary cancers prior to oral cavity or oropharyngeal cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiomic, pathomic, and clinical markersThis is a non-interventional study. | Diagnostic test | – |
Primary outcome
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
2 secondary outcomes
Time to distant metastasis
Time frame: Up to 60 months
Time to death
Time frame: Up to 60 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2023.
- Individual participant dataSharing planned: 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Tran, MRT(T), PhD principal investigator
Sunnybrook Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Neoplasm and Squamous Cell Carcinoma of Head and Neck, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to locoregional recurrence (time frame: Up to 60 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2023.