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NCT06163534Recruiting

A Longitudinal Multi-Omic Biomarker Profiling Study of Patients With Head & Neck Squamous Cell Carcinoma (HNSCC)

Tempus AI

Start Date

8/1/2024

Completion Date

3/1/2028

Summary

The study is a prospective, longitudinal, non-interventional, multicenter study of participants with HNSCC who will have tissue and blood based molecular biomarker profiling during their standard of care treatment.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * ≥18 years of age * 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: * Non-squamous histologies (eg, nasopharynx or salivary gland) * 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)

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Conditions

Head and Neck Squamous Cell Carcinoma

Locations

City of Hope

Duarte, California 91010

United States

USC/Norris Comprehensive Cancer Center

Los Angeles, California 90033

United States

University of California, Los Angeles

Los Angeles, California 90095

United States

Stanford

Palo Alto, California 94304

United States

Providence Medical Foundation

Santa Rosa, California 95403

United States

Morehouse

Atlanta, Georgia 30310

United States

Piedmont Healthcare

Atlanta, Georgia 30318

United States

Winship Cancer Institute, Emory University

Atlanta, Georgia 30322

United States

Northwestern University Feinberg School of Medicine

Chicago, Illinois 60611

United States

Cancer Care Specialists of Illinois

Decatur, Illinois 62526

United States

Illinois Cancer Care

Peoria, Illinois 61615

United States

University of Kansas

Westwood, Kansas 66205

United States

University of Maryland

Baltimore, Maryland 21202

United States

Dana Farber Cancer Institute

Boston, Massachusetts 02215

United States

Henry Ford

Detriot, Michigan 48202

United States

Karmanos Cancer Institute

Detroit, Michigan 48201

United States

Oncology Hematology Associates

Springfield, Missouri 65807

United States

Washington University in St. Louis

St Louis, Missouri 63130

United States

Mount Sinai Hospital

New York, New York 10029

United States

Sanford Fargo

Fargo, North Dakota 58102

United States

University of Cincinnati

Cincinnati, Ohio 45219

United States

Cleveland Clinic

Cleveland, Ohio 44195

United States

Ohio State University

Columbus, Ohio 43210

United States

University of Pennsylvania

Philadelphia, Pennsylvania 19104

United States

Cancer Care Associates of York

York, Pennsylvania 17403

United States

Sanford Sioux Falls

Sioux Falls, South Dakota 57104

United States

Vanderbilt University

Nashville, Tennessee 37212

United States

University of Washington

Seattle, Washington 98109

United States

ThedaCare

Appleton, Wisconsin 54911

United States

Pan American Cancer for Oncology

San Juan, 00909

Puerto Rico