RecruitingNCT06163534
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)
Sponsor
Tempus AI
Enrollment
500 participants
Start Date
Aug 1, 2024
Study Type
OBSERVATIONAL
Conditions
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
Min Age: 18 Years
Inclusion Criteria5
- ≥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 Criteria5
- 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)
Locations(29)
View Full Details on ClinicalTrials.gov
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NCT06163534
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