Recruiting

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

Sponsor:

Tempus AI

Code:

NCT06163534

Conditions

Head and Neck Squamous Cell Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief 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.

Conditions

Head and Neck Squamous Cell Carcinoma

Study ID

NCT06163534

Start date

Aug 1, 2024

Status verified date

Aug, 2026

Completion date

Mar 1, 2028

Anticipated

Primary completion date

Mar 1, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

Explore DNA, RNA, immune and other multiomic biomarkers to better understand prognostic or predictive biomarkers and to inform future research for new relevant biomarkers. [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Phoenix HNSCC

(833) 514-4187 phoenix@tempus.com

Locations

City of Hope

Recruiting

Duarte, California, United States, 91010

Contacts

Angelica Hamilton

626-218-0109 ahamilton@coh.org

Principal Investigator:

Ravi Salgia

USC/Norris Comprehensive Cancer Center

Recruiting

Los Angeles, California, United States, 90033

Contacts

Sandy Tran

sandy.tran@med.usc.edu

Principal Investigator:

Jacob Thomas

University of California, Los Angeles

Recruiting

Los Angeles, California, United States, 90095

Contacts

Youstina Zaki

310-794-4955 YZaki@mednet.ucla.edu

Principal Investigator:

Deborah Wong

Stanford

Recruiting

Palo Alto, California, United States, 94304

Contacts

Savanna Biedermann

650-497-7418 savannab@stanford.edu

Principal Investigator:

Saad Khan

Providence Medical Foundation

Recruiting

Santa Rosa, California, United States, 95403

Contacts

Davina Montelongo

707-521-3830 Davina.Montelongo@providence.org

Principal Investigator:

Ian Anderson

Mayo Clinic Florida

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

Jared Frisch

904-953-8903 Frisch.Jared@mayo.edu

Principal Investigator:

Yujie Zhao, MD, PhD

Morehouse

Recruiting

Atlanta, Georgia, United States, 30310

Contacts

Jessica Williams

404-789-3826 jrwilliams@msm.edu

Principal Investigator:

Roland Matthews

Piedmont Healthcare

Recruiting

Atlanta, Georgia, United States, 30318

Contacts

Dionne Jean

404-425-7927 Dionne.Jean@piedmont.org

Principal Investigator:

Sope Olugbile

Winship Cancer Institute, Emory University

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Johana Cruz

404-686-3925 johana.cruz@emory.edu

Principal Investigator:

Nabil Saba, MD

Northwestern University Feinberg School of Medicine

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Genesis Chase

312-695-1519 genesis.chase@northwestern.edu

Principal Investigator:

Jochen Lorch

Cancer Care Specialists of Illinois

Recruiting

Decatur, Illinois, United States, 62526

Contacts

Kaitlynn Kapp

618-589-9721 kkapp@ccsci.net

Principal Investigator:

James Wade

Illinois Cancer Care

Recruiting

Peoria, Illinois, United States, 61615

Contacts

Emilie Nkangu

309-243-3663 enkangu@illinoiscancercare.com

Principal Investigator:

Fahad Asad

University of Kansas

Recruiting

Westwood, Kansas, United States, 66205

Contacts

Emmanuel Mado

913-945-9429 emadu@kumc.edu

Principal Investigator:

Prakash Neupane

University of Maryland

Recruiting

Baltimore, Maryland, United States, 21202

Contacts

Rehan Khan

410-328-7496 Rehan.Khan@umm.edu

Principal Investigator:

Ranee Mehra

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Sage Yenari

617-632-8039 sage_yenari@dfci.harvard.edu

Principal Investigator:

Robert Haddad

Henry Ford

Recruiting

Detriot, Michigan, United States, 48202

Contacts

Molly Constantino

mcostan3@hfhs.org

Principal Investigator:

Matthew Wilkins

Karmanos Cancer Institute

Recruiting

Detroit, Michigan, United States, 48201

Contacts

Walid Sukari

sukkarim@karmanos.org

Principal Investigator:

Ammar Sukari, MD

Mayo Clinic Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Jordan Meyers

507-284-2030 Meyers.Jordan2@mayo.edu

Principal Investigator:

Patrick McGarrah, MD

Oncology Hematology Associates

Recruiting

Springfield, Missouri, United States, 65807

Contacts

Adrianna Moore

417-882-4880 adrianna.moore@aoncology.com

Principal Investigator:

V. Roger Holden, MD, PHD

Washington University in St. Louis

Recruiting

St Louis, Missouri, United States, 63130

Contacts

Samuel Williams

314-747-2626 wsamuel@wustl.edu

Principal Investigator:

Douglas Adkins, MD

Mount Sinai Hospital

Recruiting

New York, New York, United States, 10029

Contacts

Julia Miller

212-824-5378 julia.miller@mssm.edu

Principal Investigator:

Kryzsztof Misiukiewicz

Sanford Fargo

Recruiting

Fargo, North Dakota, United States, 58102

Contacts

Signe Harris

701-234-7515 signe.harris@sanfordhealth.org

Principal Investigator:

Daniel Almquist

University of Cincinnati

Recruiting

Cincinnati, Ohio, United States, 45219

Contacts

Shelby Mitchell

513-584-6195 mitchesb@ucmail.uc.edu

Principal Investigator:

Chris Lemmon, MD

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Alfred Kotarja

216-442-1947 kotarja@ccf.org

Principal Investigator:

Shlomo Koyfman

Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Harley Hamilton

614-293-6522 Harley.Hamilton@osumc.edu

Principal Investigator:

Marcelo Bonomi

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Daniel Huth

541-778-0331 Daniel.Huth@PennMedicine.upenn.edu

Principal Investigator:

Lova Sun

Cancer Care Associates of York

Recruiting

York, Pennsylvania, United States, 17403

Contacts

Clarissa Vega

cvega@cancercareyork.com

Principal Investigator:

Chanh Huynh

Sanford Sioux Falls

Recruiting

Sioux Falls, South Dakota, United States, 57104

Contacts

Brenna Many Horses

605-312-6217 Brenna.Manyhorses@SanfordHealth.org

Principal Investigator:

Steven Powell

Vanderbilt University

Recruiting

Nashville, Tennessee, United States, 37212

Contacts

Ilyana Ilieva

615-936-0960 ilyana.ilieva@vumc.org

Principal Investigator:

Jennifer Choe

University of Washington

Recruiting

Seattle, Washington, United States, 98109

Contacts

Marcus Schoenfeld

206-606-7487 msschoen@fredhutch.org

Principal Investigator:

Cristinia Rodriguez

ThedaCare

Recruiting

Appleton, Wisconsin, United States, 54911

Contacts

Sarah Loether

920-364-3604 sarah.loether@thedacare.org

Principal Investigator:

Matthias Weiss

More Information

Sponsor

Tempus AI

Last update posted

Sep 3, 2026

Last verified

Aug, 2026

Keywords

Oncology
Biomarkers
Genomic Profiling
HNSCC
Cancer
Observational
Registry
Precision Medicine
NGS

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Tempus AI on 2026-09-03.