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

RECRUITINGSponsored by Tempus AI
Actively Recruiting
SponsorTempus AI
Started2024-08-01
Est. completion2028-03-01
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations28 sites
View on ClinicalTrials.gov →

NCT06163534

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

Age: 18 Years+Healthy volunteers accepted
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)

Conditions2

CancerHead and Neck Squamous Cell Carcinoma

Locations28 sites

City of Hope
Duarte, California, 91010
Sarah Ursusursu@coh.org
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Sandy Transandy.tran@med.usc.edu
University of California, Los Angeles
Los Angeles, California, 90095
Youstina Zaki310-794-4955YZaki@mednet.ucla.edu
Stanford
Palo Alto, California, 94304
Savanna Biedermann650-497-7418savannab@stanford.edu
Providence Medical Foundation
Santa Rosa, California, 95403
Davina Montelongo707-521-3830Davina.Montelongo@providence.org

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