NCT02147418

Brief Summary

Cancer of the oropharynx (middle, side and back walls of the throat; back of the tongue; soft palate, and tonsils), or oropharyngeal squamous cell carcinoma (OPSCC), has been on the rise in the United States. Human papillomavirus (HPV) has been recognized in many of these cancers, and testing for HPV has contributed to the higher reported rates of OPSCC. In this study, our goal is to develop a new test that can detect certain HPV proteins in the blood or saliva to help improve detection of OPSCC.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 22, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 26, 2014

Completed
9 months until next milestone

Study Start

First participant enrolled

February 25, 2015

Completed
9.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 8, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2024

Completed
Last Updated

May 22, 2025

Status Verified

May 1, 2025

Enrollment Period

9.2 years

First QC Date

May 22, 2014

Last Update Submit

May 20, 2025

Conditions

Oropharyngeal Cancer

Keywords

Head and neck cancerThroat cancerHuman papillomavirusHPVExosomeDiagnosticEarly Detection

Outcome Measures

Primary Outcomes (1)

  • Cultured Cell Exosome Protein Signature Outcome Measure

    The presence of unique proteins obtained from primary cell cultures derived from HPV-OPSCC confirmed patients will be compared to normal tonsillar epithelial cells and established cell lines. The distribution of these protein signatures will be compared in HPV-OPSCC and normal epithelial cells.

    1 month

Other Outcomes (1)

  • Exosome Signatures Oropharyngeal Rinse Measure

    1 month

Study Arms (3)

Group 1: HPV-positive Cancer

Oropharyngeal cancer patients testing positive for human papillomavirus (HPV)

Group 2: HPV-positive Cancer

Oropharyngeal cancer patients who test positive for human papillomavirus (HPV)

Group 3: Healthy Controls

Patients with benign conditions

Eligibility Criteria

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

The patient population will consist of adults presenting to the Division of Otolaryngology - Head and Neck Surgery at the University of New Mexico with previously untreated OPSCC. Both HPV-positive and HPV-negative malignancies will be collected as the study and control groups, respectively. In addition, saliva samples will be collected from patients presenting with benign conditions as a further negative control.

You may qualify if:

  • Male or Female
  • Age greater than or equal to 18
  • Previously untreated, pathologically confirmed OPSCC (HPV+ or HPV-)
  • Ability to understand study information and provide written consent for participation.
  • Male or Female
  • Age greater than or equal to 18
  • Ability to understand study information and provide written consent for participation

You may not qualify if:

  • Age less than 18 years
  • Prisoners
  • Pregnant women
  • Patients with mental disability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of New Mexico Cancer Center

Albuquerque, New Mexico, 87131-0001, United States

Location

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

All oropharyngeal rinse (gargle) specimens will be processed within 24 hours of collection. Any remaining material after testing will be stored for a period not to exceed 1 year in a secure location.

MeSH Terms

Conditions

Oropharyngeal NeoplasmsHead and Neck NeoplasmsDisease

Condition Hierarchy (Ancestors)

Pharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsNeoplasms by SiteNeoplasmsPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Andrew Cowan, MD

    University of New Mexico Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 22, 2014

First Posted

May 26, 2014

Study Start

February 25, 2015

Primary Completion

May 8, 2024

Study Completion

July 25, 2024

Last Updated

May 22, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)