A Longitudinal Multi-Omic Biomarker Profiling Study of Patients With Head & Neck Squamous Cell Carcinoma (HNSCC)
NCT ID: NCT06163534
Last Updated: 2025-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
500 participants
OBSERVATIONAL
2024-08-01
2028-03-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Metastatic or unresectable recurrent HNSCC
Up to 500 participants (including primary tumor location of pharynx, larynx, oral cavity and oropharynx) with metastatic or unresectable recurrent HNSCC who are intended for first line immunotherapy or combination therapy. No intervention.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Willing and able to provide informed consent
* Histologically- or cytologically-confirmed metastatic or unresectable, recurrent HNSCC unsuitable for local therapies
* Intended for first line anti-PD1 or PDL1 monotherapy or combination therapy
* Must submit tumor tissue sample representative of current disease per laboratory manual
Exclusion Criteria
* Relapse or recurrence within 6 months of first line chemotherapy and / or chemoradiotherapy
* Tumors that are PD-L1 negative (CPS \<1)
* Clinical evidence of an active second invasive malignancy within \<2 years of enrollment with the exception of stable prostate cancer on watchful waiting, in situ cervical cancer, in situ breast carcinoma or localized non-melanoma skin cancers
* Unable to comply with study procedures (i.e., not willing or able to have additional blood samples collected)
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Tempus AI
INDUSTRY
Responsible Party
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Principal Investigators
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Virginia Rhodes, MD
Role: STUDY_DIRECTOR
Tempus AI, Inc.
Locations
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City of Hope
Duarte, California, United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States
University of California, Los Angeles
Los Angeles, California, United States
Stanford
Palo Alto, California, United States
Providence Medical Foundation
Santa Rosa, California, United States
Morehouse
Atlanta, Georgia, United States
Piedmont Healthcare
Atlanta, Georgia, United States
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States
Cancer Care Specialists of Illinois
Decatur, Illinois, United States
Illinois Cancer Care
Peoria, Illinois, United States
University of Kansas
Westwood, Kansas, United States
University of Maryland
Baltimore, Maryland, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Oncology Hematology Associates
Springfield, Missouri, United States
Washington University in St. Louis
St Louis, Missouri, United States
Mount Sinai Hospital
New York, New York, United States
Sanford Fargo
Fargo, North Dakota, United States
University of Cincinnati
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Ohio State University
Columbus, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Cancer Care Associates of York
York, Pennsylvania, United States
Sanford Sioux Falls
Sioux Falls, South Dakota, United States
Vanderbilt University
Nashville, Tennessee, United States
University of Washington
Seattle, Washington, United States
ThedaCare
Appleton, Wisconsin, United States
Pan American Cancer for Oncology
San Juan, , Puerto Rico
Countries
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Central Contacts
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Facility Contacts
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Samuel Williams
Role: primary
References
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Other Identifiers
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Pro00074943
Identifier Type: OTHER
Identifier Source: secondary_id
TP-CA-006
Identifier Type: -
Identifier Source: org_study_id
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