A Longitudinal Multi-Omic Biomarker Profiling Study of Patients With Head & Neck Squamous Cell Carcinoma (HNSCC)
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Registration Number
- NCT06163534
- Lead Sponsor
- Tempus AI
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 500
- ≥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
- 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)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Explore DNA, RNA, immune and other multiomic biomarkers to better understand prognostic or predictive biomarkers and to inform future research for new relevant biomarkers. 5 years Use NGS, ctNDA assessments, RNA analysis, and other multiomic testing to uncover biomarkers of collected blood and tissue samples that may predict outcomes, identify markers related to disease, identify markers related to mechanism of drug action, and inform future research.
- Secondary Outcome Measures
Name Time Method Explore changes in relevant DNA, RNA, immune and multiomic biomarkers in longitudinal blood samples, and diagnostic and progression biopsy samples, to understand real-world outcomes and resistance mechanisms. 5 years Correlate biomarkers of collected blood and tissue samples with standard of care therapy real-world outcomes such as overall survival, progression free survival, time to next treatment, and time to treatment discontinuation.
Explore changes in ctDNA from longitudinal blood samples to assess ctDNA as a response biomarker. 5 years Assess changes in ctNDA of collected blood samples using ctDNA clearance factors such as time to clearance, best overall clearance rate, best confirmed clearance, duration, time to ctDNA recurrence with standard of care therapy real-world outcomes such as overall survival, progression free survival, time to next treatment, and time to treatment discontinuation.
Trial Locations
- Locations (17)
City of Hope
🇺🇸Duarte, California, United States
USC/Norris Comprehensive Cancer Center
🇺🇸Los Angeles, California, United States
Morehouse
🇺🇸Atlanta, Georgia, United States
Northwestern University Feinberg School of Medicine
🇺🇸Chicago, Illinois, United States
Cancer Care Specialists of Illinois
🇺🇸Decatur, Illinois, United States
Illinois Cancer Care
🇺🇸Peoria, Illinois, United States
University of Kansas
🇺🇸Westwood, Kansas, United States
Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Washington University in St. Louis
🇺🇸Saint Louis, Missouri, United States
Oncology Hematology Associates
🇺🇸Springfield, Missouri, United States
Mount Sinai Hospital
🇺🇸New York, New York, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Cancer Care Associates of York
🇺🇸York, Pennsylvania, United States
Vanderbilt University
🇺🇸Nashville, Tennessee, United States
Pan American Cancer for Oncology
🇵🇷San Juan, Puerto Rico