Multidimensional and Multimodal Profiling of Oropharyngea... | NCT05880797

Studies
Multidimensional and Multimodal Profiling of Oropharyngeal Carcinoma

NCT05880797

Sponsor

Stanford University

Status

Recruiting

Last Update Posted

Apr 13, 2026Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Oropharyngeal Carcinoma
Human Papilloma Virus

Interventions

Not provided

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-2023-05592	Registry Identifier	National Cancer Institute Clinical Trials Reporting Program

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

Jul 7, 2023Actual

Primary Completion Date

Aug 2026Estimated

Completion Date

Aug 2026Estimated

First Submitted Date

May 17, 2023

First Submission Date that Met QC Criteria

May 25, 2023

First Posted Date

May 30, 2023Actual

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 9, 2026

Last Update Posted Date

Apr 13, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to better understand the natural history of oropharyngeal carcinoma (OPC), with or without an association with the human papilloma virus (HPV). For this study, the investigators plan to collect blood from OPC patients prior to treatment and at six subsequent time points.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

1,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sample collection	30-50cc of blood	prior to start of treatment
Sample collection	30-50cc of blood	up to 36 months post-op

Secondary Outcomes

Measure	Description	Time Frame
tumor sample	tumor sample (FFPE) or fresh tissue post-excision or surgery, this will only be collected, if and when feasible, after the tumor has been removed post procedure.	Day 1

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients diagnosed with oropharyngeal carcinoma or patients with cancer of the unknown primary that is HPV associated, or possibly deemed to be originating from the oropharynx.

Exclusion Criteria:

Not willing to sign consent

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

Participants with known or suspected oropharyngeal carcinoma. All patients with OPC getting surgery at Stanford are invited to participate in the study.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Nikita Bedi	Contact	(650) 723-5957		nbedi@stanford.edu

Overall Officials

Name	Affiliation	Role
Chris Holsinger, MD	Stanford University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Stanford University	Recruiting	Palo Alto	California	94305	United States

Condition Browse Module

MeSH Terms

ID	Term
D009959	Oropharyngeal Neoplasms

Ancestor Terms

ID	Term
D010610	Pharyngeal Neoplasms
D010039	Otorhinolaryngologic Neoplasms
D006258	Head and Neck Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided

Description

The investigators propose to collect blood 30-50cc of blood from Pre-treatment up to 36 month post treatment (+/- 6 months or at the closest visit the patient is being seen for their standard of care visit).

The investigators also will collect tumor sample (FFPE) or fresh tissue post-excision or surgery and also digitize the de-identified tissue slides (H&E and/or HPV biomarker slides). No extra tissue will be taken at time of procedure, this will only be collected, if and when feasible, after the tumor has been removed post procedure.