## Protocol Section
### Identification Module
**NCT ID:** NCT06420219

**Brief Title:** An Integrative Multi-Omic Characterization of Head and Neck Carcinogenesis, Progression and Recurrence

**Official Title:** An Integrative Multi-Omic Characterization of Head and Neck Carcinogenesis, Progression and Recurrence

#### Organization Study ID Info
**ID:** 7H-23-4
#### Organization
**Class:** OTHER
**Full Name:** University of Southern California
#### Secondary ID Infos
**Domain:** CTRP (Clinical Trial Reporting Program)
**ID:** NCI-2024-01559
**Type:** REGISTRY
**Domain:** USC / Norris Comprehensive Cancer Center
**ID:** 7H-23-4
**Type:** OTHER
**ID:** P30CA014089
**Link:** https://reporter.nih.gov/quickSearch/P30CA014089
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2029-03-25

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-20

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2028-03-25

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-03-25

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-17
**Type:** ACTUAL
**Study First Submit Date:** 2024-03-25
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module

#### Collaborators

**Class:** NIH

**Name:** National Cancer Institute (NCI)

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Southern California

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Is US Export:** False

**Oversight Has DMC:** True

### 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.

### Conditions Module

**Conditions:**

- Head and Neck Carcinoma

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 50

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Other: Non-Interventional Study

**Label:** Observational

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Observational

**Description:** Non-interventional study

**Name:** Non-Interventional Study

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Measure:** Overall survival

**Time Frame:** Up to 5 years

**Measure:** Disease free survival

**Time Frame:** Up to 5 years

### 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

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Patients with a new diagnosis of head and neck cancer

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** sandy.tran@med.usc.edu

**Name:** Sandy Tran, MS

**Phone:** 323-865-0451

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Los Angeles

**Contacts:**

***Contact 1:***

- **Email:** Sandy.tran@med.usc.edu

- **Name:** Sandy Tran, MS

- **Phone:** 323-865-0451

- **Role:** CONTACT

***Contact 2:***

- **Name:** Albert Y. Han, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** USC / Norris Comprehensive Cancer Center

**State:** California

**Status:** RECRUITING

**Zip:** 90033

#### Overall Officials

**Official 1:**

**Affiliation:** University of Southern California

**Name:** Albert Y Han, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

- ID: D000009385

- Term: Neoplastic Processes

- ID: D000009369

- Term: Neoplasms

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M5534

- Name: Carcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M14850

- Name: Recurrence

- Relevance: HIGH

- As Found: Recurrence

- ID: M30145

- Name: Carcinogenesis

- Relevance: HIGH

- As Found: Carcinogenesis

- ID: M20559

- Name: Disease Progression

- Relevance: LOW

- As Found: Unknown

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: M12330

- Name: Neoplastic Processes

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000063646

- Term: Carcinogenesis

- ID: D000012008

- Term: Recurrence

### Misc Info Module

- Version Holder: 2024-05-31
