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

NCT06163534

RecruitingN/A

Sponsor: Tempus AI

Conditions: Head and Neck Squamous Cell Carcinoma

Countries: United States, Puerto Rico

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 overview

Sex: ALL

Age: 18 Years to

Healthy volunteers: No

Study type: OBSERVATIONAL

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)
Locations (30)
  • Duarte, California, United States
  • Los Angeles, California, United States
  • Los Angeles, California, United States
  • Palo Alto, California, United States
  • Santa Rosa, California, United States
  • Atlanta, Georgia, United States
  • Atlanta, Georgia, United States
  • Atlanta, Georgia, United States
  • Chicago, Illinois, United States
  • Decatur, Illinois, United States
  • Peoria, Illinois, United States
  • Westwood, Kansas, United States
  • Baltimore, Maryland, United States
  • Boston, Massachusetts, United States
  • Detriot, Michigan, United States
  • Detroit, Michigan, United States
  • Springfield, Missouri, United States
  • St Louis, Missouri, United States
  • New York, New York, United States
  • Fargo, North Dakota, United States
  • Cincinnati, Ohio, United States
  • Cleveland, Ohio, United States
  • Columbus, Ohio, United States
  • Philadelphia, Pennsylvania, United States
  • York, Pennsylvania, United States
  • Sioux Falls, South Dakota, United States
  • Nashville, Tennessee, United States
  • Seattle, Washington, United States
  • Appleton, Wisconsin, United States
  • San Juan, Puerto Rico