NCT05880797

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
2mo left

Started Jul 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress92%
Jul 2023Aug 2026

First Submitted

Initial submission to the registry

May 17, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 30, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

July 7, 2023

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

3.1 years

First QC Date

May 17, 2023

Last Update Submit

April 9, 2026

Conditions

Oropharyngeal CarcinomaHuman Papilloma Virus

Outcome Measures

Primary Outcomes (2)

  • 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 (1)

  • tumor sample

    Day 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • Not willing to sign consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University

Palo Alto, California, 94305, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

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.

MeSH Terms

Conditions

Oropharyngeal Neoplasms

Condition Hierarchy (Ancestors)

Pharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNeoplasmsPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Chris Holsinger, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nikita Bedi

CONTACT

(650) 723-5957nbedi@stanford.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2023

First Posted

May 30, 2023

Study Start

July 7, 2023

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

April 13, 2026

Record last verified: 2026-04

Locations

US(1)