RECRUITING

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

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Conditions

Head and Neck Squamous Cell CarcinomaOncologyBiomarkersGenomic ProfilingHNSCCCancerObservationalRegistryPrecision MedicineNGS

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

TEMPUS PHOENIX HNSCC STUDY: a Longitudinal Multi-Omic Biomarker Profiling Study of Patients with Head & Neck Squamous Cell Carcinoma (HNSCC)

Quick Facts

Study Start:2024-08-01
Study Completion:2028-03-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06163534

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * ≥18 years of age
  2. * Willing and able to provide informed consent
  3. * Histologically- or cytologically-confirmed metastatic or unresectable, recurrent HNSCC unsuitable for local therapies
  4. * Intended for first line anti-PD1 or PDL1 monotherapy or combination therapy
  5. * Must submit tumor tissue sample representative of current disease per laboratory manual
  1. * Non-squamous histologies (eg, nasopharynx or salivary gland)
  2. * Relapse or recurrence within 6 months of first line chemotherapy and / or chemoradiotherapy
  3. * Tumors that are PD-L1 negative (CPS \<1)
  4. * 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
  5. * Unable to comply with study procedures (i.e., not willing or able to have additional blood samples collected)

Contacts and Locations

Study Contact

Phoenix HNSCC
CONTACT
(833) 514-4187
phoenix@tempus.com

Principal Investigator

Virginia Rhodes, MD
STUDY_DIRECTOR
Tempus AI, Inc.

Study Locations (Sites)

City of Hope
Duarte, California, 91010
United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033
United States
Cancer Care Specialists of Illinois
Decatur, Illinois, 62526
United States
Illinois Cancer Care
Peoria, Illinois, 61615
United States
Washington University in St. Louis
Saint Louis, Missouri, 63130
United States
Oncology Hematology Associates
Springfield, Missouri, 65807
United States
Mount Sinai Hospital
New York, New York, 10029
United States
Cancer Care Associates of York
York, Pennsylvania, 17403
United States

Collaborators and Investigators

Sponsor: Tempus AI

  • Virginia Rhodes, MD, STUDY_DIRECTOR, Tempus AI, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-01
Study Completion Date2028-03-01

Study Record Updates

Study Start Date2024-08-01
Study Completion Date2028-03-01

Terms related to this study

Keywords Provided by Researchers

  • Oncology
  • Biomarkers
  • Genomic Profiling
  • HNSCC
  • Cancer
  • Observational
  • Registry
  • Precision Medicine
  • NGS

Additional Relevant MeSH Terms

  • Head and Neck Squamous Cell Carcinoma