NCT06163534 · Tempus AI
A Longitudinal Multi-Omic Biomarker Profiling Study of Patients With Head & Neck Squamous Cell Carcinoma (HNSCC)
What this study is about
The study is a forward-looking, longitudinal, non-interventional, conducted at multiple hospitals study of participants with HNSCC who will have tissue and blood based molecular biomarker profiling during their the usual treatment treatment.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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)
Where
- Duarte, California
- Los Angeles, California
- Palo Alto, California
- Santa Rosa, California
- Atlanta, Georgia
- Chicago, Illinois
- Decatur, Illinois
- Peoria, Illinois
- Westwood, Kansas
- Baltimore, Maryland
- Boston, Massachusetts
- Detriot, Michigan
And 14 more locations — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 12, 2026 · Source of record for eligibility and locations