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

NCT06163534 | Recruiting

• 2 other identifiers: TP-CA-006Pro00074943
• Study Type: observational
• Target: 500
• Locations: 2 countries
• Sites: 29

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

Keywords

Oncology; Biomarkers; Genomic Profiling; HNSCC; Cancer; Observational; Registry; Precision Medicine; NGS

Outcome Measures

Primary Outcomes (1)

• Explore DNA, RNA, immune and other multiomic biomarkers to better understand prognostic or predictive biomarkers and to inform future research for new relevant biomarkers.

  Use NGS, ctNDA assessments, RNA analysis, and other multiomic testing to uncover biomarkers of collected blood and tissue samples that may predict outcomes, identify markers related to disease, identify markers related to mechanism of drug action, and inform future research.

  5 years

Secondary Outcomes (2)

• Explore changes in relevant DNA, RNA, immune and multiomic biomarkers in longitudinal blood samples, and diagnostic and progression biopsy samples, to understand real-world outcomes and resistance mechanisms.

  5 years

• Explore changes in ctDNA from longitudinal blood samples to assess ctDNA as a response biomarker.

  5 years

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This protocol targets patients with metastatic or unresectable, recurrent HNSCC intended for first line immunotherapy or combination therapy.

You may qualify if:

• ≥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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Tempus AI: lead
• AstraZeneca: collaborator

Study Sites (29)

City of Hope

Duarte, California, 91010, United States

RECRUITING

USC/Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

RECRUITING

University of California, Los Angeles

Los Angeles, California, 90095, United States

RECRUITING

Stanford

Palo Alto, California, 94304, United States

RECRUITING

Providence Medical Foundation

Santa Rosa, California, 95403, United States

RECRUITING

Morehouse

Atlanta, Georgia, 30310, United States

RECRUITING

Piedmont Healthcare

Atlanta, Georgia, 30318, United States

RECRUITING

Winship Cancer Institute, Emory University

Atlanta, Georgia, 30322, United States

RECRUITING

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

RECRUITING

Cancer Care Specialists of Illinois

Decatur, Illinois, 62526, United States

RECRUITING

Illinois Cancer Care

Peoria, Illinois, 61615, United States

RECRUITING

University of Kansas

Westwood, Kansas, 66205, United States

RECRUITING

University of Maryland

Baltimore, Maryland, 21202, United States

RECRUITING

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

RECRUITING

Oncology Hematology Associates

Springfield, Missouri, 65807, United States

RECRUITING

Washington University in St. Louis

St Louis, Missouri, 63130, United States

RECRUITING

Mount Sinai Hospital

New York, New York, 10029, United States

RECRUITING

Sanford Fargo

Fargo, North Dakota, 58102, United States

RECRUITING

University of Cincinnati

Cincinnati, Ohio, 45219, United States

RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

Ohio State University

Columbus, Ohio, 43210, United States

RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Cancer Care Associates of York

York, Pennsylvania, 17403, United States

RECRUITING

Sanford Sioux Falls

Sioux Falls, South Dakota, 57104, United States

RECRUITING

Vanderbilt University

Nashville, Tennessee, 37212, United States

RECRUITING

University of Washington

Seattle, Washington, 98109, United States

RECRUITING

ThedaCare

Appleton, Wisconsin, 54911, United States

RECRUITING

Pan American Cancer for Oncology

San Juan, 00909, Puerto Rico

RECRUITING

Related Publications (29)

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Biospecimen

Retention: SAMPLES WITH DNA

Blood and tissue will be collected.

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Head and Neck Neoplasms; Neoplasms by Site

Study Officials

• Virginia Rhodes, MD

  Tempus AI, Inc.

  STUDY DIRECTOR

Central Study Contacts

Phoenix HNSCC

CONTACT

(833) 514-4187; phoenix@tempus.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2023
• First Posted: December 11, 2023
• Study Start: August 1, 2024
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: March 4, 2026

Record last verified: 2026-03

Locations

US (28); PR (1)