NCT02365844

Brief Summary

The purpose of this study is to characterize the blood supply at the base of the tongue and within the tonsil region. We hypothesize that high-resolution Narrow Band Imaging (NBI) will improve the diagnosis of oropharyngeal carcinoma (OPC). The goal is to provide the better assessment of tumor and thus providing better preoperative expectations to patients with OPC or tumor extent prior to radiation therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
81

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2015

Typical duration 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

February 11, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 19, 2015

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 27, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 27, 2018

Completed
Last Updated

March 1, 2019

Status Verified

February 1, 2019

Enrollment Period

3.6 years

First QC Date

February 11, 2015

Last Update Submit

February 27, 2019

Conditions

Oropharyngeal CarcinomaOropharynx Cancer

Keywords

Narrow Band Imagingoropharyngeal carcinoma

Outcome Measures

Primary Outcomes (1)

  • assessment of differential vascularity between normal and clinically apparent tumor with in the specified sites of oropharynx, using standard white-light endoscopy and narrow-band imaging

    endoscopy of the oropharynx using white-light and narrow-Band imaging

    30 minutes

Eligibility Criteria

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

Stanford Cancer Center patients with oropharyngeal carcinoma

You may qualify if:

  • age 18 years or older
  • Written informed consent
  • Patients with oropharyngeal carcinoma

You may not qualify if:

  • Tumors of the oral cavity or nasopharynx

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University, School of Medicine

Stanford, California, 95305, United States

Location

MeSH Terms

Conditions

Oropharyngeal Neoplasms

Condition Hierarchy (Ancestors)

Pharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNeoplasmsPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Chris Holsinger

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2015

First Posted

February 19, 2015

Study Start

February 1, 2015

Primary Completion

August 27, 2018

Study Completion

August 27, 2018

Last Updated

March 1, 2019

Record last verified: 2019-02

Locations

US(1)