Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06163534

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pan American Cancer for Oncology, San Juan, Puerto Rico

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

    Time frame: 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 outcomes

  1. 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.

    Time frame: 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.

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

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Phoenix HNSCC

CONTACT

[email protected]

(833) 514-4187

Sponsors and collaborators

Lead sponsor

Tempus AI

Industry

Collaborators

  • AstraZeneca

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Dec 11, 2023
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.