NCT06163534 A Longitudinal Multi-Omic Biomarker Profiling Study of Patients With Head & Neck Squamous Cell Carcinoma (HNSCC)
| NCT ID | NCT06163534 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tempus AI |
| Condition | Head and Neck Squamous Cell Carcinoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2024-08-01 |
| Primary Completion | 2028-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2024-08-01 with a primary completion date of 2028-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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)
Contact & Investigator
Virginia Rhodes, MD
STUDY DIRECTOR
Tempus AI, Inc.
Frequently Asked Questions
Who can join the NCT06163534 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Head and Neck Squamous Cell Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06163534 currently recruiting?
Yes, NCT06163534 is actively recruiting participants. Contact the research team at phoenix@tempus.com for enrollment information.
Where is the NCT06163534 trial being conducted?
This trial is being conducted at Duarte, United States, Los Angeles, United States, Los Angeles, United States, Palo Alto, United States and 11 additional locations.
Who is sponsoring the NCT06163534 clinical trial?
NCT06163534 is sponsored by Tempus AI. The principal investigator is Virginia Rhodes, MD at Tempus AI, Inc.. The trial plans to enroll 500 participants.