An Integrative Multi-Omic Characterization of Head and Neck Carcinogenesis, Progression and Recurrence

This study evaluates the cell and biomarkers associated with the aggressive behavior of cancer.

Study Overview

• Status: Recruiting
• Conditions: Head and Neck Carcinoma
• Intervention / Treatment: Other: Non-Interventional Study

Detailed Description

PRIMARY OBJECTIVE:

I. High-resolution single-cell profiling of Cancer-associated fibroblasts (CAFs) in Human papillomavirus (HPV)+ Oropharyngeal Squamous Cell Carcinoma (OPSCC) and metastatic lymph nodes.

OUTLINE: This is an observational study.

Patients undergo photography, blood sample collection, tissue collection and have their medical records reviewed on study.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Sandy Tran, MS; Phone Number: 323-865-0451; Email: Sandy.tran@med.usc.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • Recruiting
      • USC / Norris Comprehensive Cancer Center
      • Contact: Sandy Tran, MS; Phone Number: 323-865-0451; Email: Sandy.tran@med.usc.edu
      • Principal Investigator: Albert Y. Han, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with a new diagnosis of head and neck cancer

Description

Inclusion Criteria:

• Diagnosis/disease status: New diagnosis of head and neck cancer
• Allowable type and amount of prior therapy: No prior treatment
• Age ≥ 18 years.
• Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

• Patients who have had treatment of head and neck cancer

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Observational; Patients undergo photography, blood sample collection, tissue collection and have their medical records reviewed on study.	Other: Non-Interventional Study; Non-interventional study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall survival	Up to 5 years
Disease free survival	Up to 5 years

Collaborators and Investigators

• Sponsor: University of Southern California
• Collaborators: National Cancer Institute (NCI); American Academy of Otolaryngology-Head and Neck Surgery Foundation
• Investigators: Principal Investigator: Albert Y Han, MD, University of Southern California

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2024
• Primary Completion (Estimated): March 25, 2028
• Study Completion (Estimated): March 25, 2029

Study Registration Dates

• First Submitted: March 25, 2024
• First Submitted That Met QC Criteria: May 16, 2024
• First Posted (Actual): May 17, 2024

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 24, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Disease Attributes; Neoplastic Processes; Recurrence; Carcinogenesis
• Other Study ID Numbers: 7H-23-4 (Other Identifier: USC / Norris Comprehensive Cancer Center); P30CA014089 (U.S. NIH Grant/Contract); NCI-2024-01559 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No