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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06163534

Enrollment

500

Registered

2023-12-11

Start date

2024-08-01

Completion date

2028-03-01

Last updated

2026-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Squamous Cell Carcinoma

Keywords

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

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
Explore DNA, RNA, immune and other multiomic biomarkers to better understand prognostic or predictive biomarkers and to inform future research for new relevant biomarkers.	5 years	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.

Secondary

Measure	Time frame	Description
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	Correlate biomarkers of collected blood and tissue samples with standard of care therapy real-world outcomes such as overall survival, progression free survival, time to next treatment, and time to treatment discontinuation.
Explore changes in ctDNA from longitudinal blood samples to assess ctDNA as a response biomarker.	5 years	Assess changes in ctNDA of collected blood samples using ctDNA clearance factors such as time to clearance, best overall clearance rate, best confirmed clearance, duration, time to ctDNA recurrence with standard of care therapy real-world outcomes such as overall survival, progression free survival, time to next treatment, and time to treatment discontinuation.

Countries

Puerto Rico, United States

Contacts

CONTACTPhoenix HNSCC

phoenix@tempus.com(833) 514-4187

STUDY_DIRECTORVirginia Rhodes, MD

Tempus AI, Inc.

Outcome results