MedTrace Logo

Saliva-based Detection of CD44

NCT03148665 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 85

Last updated 2022-08-17

No results posted yet for this study

Summary

The purpose of this study is to test the ability of OncAlert™ to screen for cancer and the reappearance of cancer. OncAlert™ was developed by Vigilant Biosciences, a collaborator in this research study. OncAlert™ is an oral rinse which is spit into a cup and sent to a laboratory for analysis. OncAlert™ is considered experimental by the FDA because it is not approved for the screening of cancer.

Conditions

  • Oral Cavity Squamous Cell Carcinoma
  • Oropharynx Squamous Cell Carcinoma
  • Squamous Cell Carcinoma of the Oropharynx
  • Squamous Cell Carcinoma of the Head and Neck

Interventions

DEVICE

OncAlert

A noninvasive point of care salivary rinse test performed as 1) a one-time test for control subjects, 2) at pretreatment and post treatment 3,6, 12, and 18 month time points in oral cavity/oropharynx cancer patients

Sponsors & Collaborators

  • Vigilant Biosciences, Inc.

    collaborator INDUSTRY

  • Greater Baltimore Medical Center

    collaborator OTHER

  • San Diego Veterans Healthcare System

    collaborator FED

  • NYU Langone Health

    collaborator OTHER

  • Johns Hopkins University

    collaborator OTHER

  • Joseph Califano

    lead OTHER

Principal Investigators

  • Joseph Califano, MD · University of California, San Diego

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-04-14
Primary Completion
2019-04-10
Completion
2022-05-03
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03148665 on ClinicalTrials.gov