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NCT04086849 Clinical Trial

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

Squamous Cell Carcinoma of Head and Neck Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04086849
Other study ID # 087-2019
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 30, 2019
Est. completion date April 5, 2021

Study information
Verified date September 2022
Source Sunnybrook Health Sciences Centre
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 450
Est. completion date April 5, 2021
Est. primary completion date March 26, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Canada Sunnybrook Health Sciences Centre Toronto Ontario

Sponsors (1)
Lead Sponsor Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Time to distant metastasis Evaluating onset of distant metastasis Up to 60 months
Secondary Time to death Evaluating time to cancer-related death Up to 60 months
See also
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Completed NCT02537223 - Phase I Study of BYL719 in Combination With Cisplatin and Radiotherapy in Patients With Squamous Cell Head and Neck Cancer Phase 1
Completed NCT00824343 - A Phase II Clinical Trial to Study the Efficacy and Safety of a New Drug P276-00 in Treatment of Recurrent and/or Locally Advanced Head and Neck Cancer Phase 2
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Active, not recruiting NCT05061420 - A Study of SAR444245 Combined With Other Anticancer Therapies for the Treatment of Participants With HNSCC (Master Protocol) (Pegathor Head and Neck 204) Phase 2
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Not yet recruiting NCT05845307 - Randomized Pre-surgical Window-of-Opportunity Trial of TTI-101 in Patients With Stage II-IV Resectable HPV-negative Squamous Cell Carcinoma of the Head and Neck Early Phase 1
Active, not recruiting NCT04489888 - A Study of Pembrolizumab (MK-3475) Plus Carboplatin and Paclitaxel as First-line Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (MK-3475-B10/KEYNOTE B10) Phase 4
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Completed NCT00756444 - A Randomized Phase 2 Pharmacokinetic Trial of Chemotherapy With or Without Panitumumab in Patients With Metastatic and/or Recurrent Squamous Cell Carcinoma of the Head and Neck Phase 2