An Integrative Multi-Omic Characterization of Head and Ne... | NCT06420219

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

NCT06420219

Sponsor

University of Southern California

Status

Recruiting

Last Update Posted

Apr 28, 2026Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Head and Neck Carcinoma

Interventions

Non-Interventional Study

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
NCI-2024-01559	Registry Identifier	CTRP (Clinical Trial Reporting Program)
7H-23-4	Other Identifier	USC / Norris Comprehensive Cancer Center
P30CA014089	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 25, 2024Actual

Primary Completion Date

Mar 25, 2028Estimated

Completion Date

Mar 25, 2029Estimated

First Submitted Date

Mar 25, 2024

First Submission Date that Met QC Criteria

May 16, 2024

First Posted Date

May 17, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 24, 2026

Last Update Posted Date

Apr 28, 2026Actual

Name	Class
National Cancer Institute (NCI)	NIH
American Academy of Otolaryngology-Head and Neck Surgery Foundation	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Observational		Patients undergo photography, blood sample collection, tissue collection and have their medical records reviewed on study.	Other: Non-Interventional Study

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Non-Interventional Study	Other	Non-interventional study	Observational

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with a new diagnosis of head and neck cancer

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sandy Tran, MS	Contact	323-865-0451		sandy.tran@med.usc.edu

Overall Officials

Name	Affiliation	Role
Albert Y Han, MD	University of Southern California	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
USC / Norris Comprehensive Cancer Center	Recruiting	Los Angeles	California	90033	United States