Summary

for people ages 18 years and up (full criteria)
healthy people welcome
at La Jolla, California and other locations
study started
estimated completion:
Joseph Califano

Description

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.

Official Title

A Prospective, Multi-site Trial of a Point of Care Saliva Based Detection Test Based on Soluble CD44 (OncAlert) for Presence of Disease in Previously Untreated Oral Cavity and Oropharynx Squamous Cell Carcinoma

Details

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

Keywords

Oral Cavity Squamous Cell Carcinoma Oropharynx Squamous Cell Carcinoma Squamous Cell Carcinoma of the Oropharynx Squamous Cell Carcinoma of the Head and Neck Oral Cancer Head and Neck Cancer Carcinoma Carcinoma, Squamous Cell Oropharyngeal Neoplasms Head and Neck Neoplasms OncAlert Cancer population

Eligibility

You can join if…

Open to people ages 18 years and up

  • Patient has the ability to understand and the willingness to sign a written informed consent.
  • Previously untreated, measurable squamous cell carcinoma of the oral cavity or oropharynx with no evidence of distant metastasis, T1-4N0-3M0
  • No prior history of treated upper aerodigestive tract cancer
  • No concurrent, second, active malignancy other than oral cavity and/or oropharynx cancer
  • Planned to undergo treatment with curative intent
  • Able to follow up after therapy at 3, 6, 12, and 18 months after completion of therapy during routine post treatment follow up
  • For control subjects: no evidence or history of upper aerodigestive tract cancer
  • For control subjects: absence of any suspected or confirmed active malignancy at time of enrollment
  • Patients may have had prior therapy for malignancy other than upper aerodigestive malignancy completed 2 years prior to enrollment if they have been disease free since completion of therapy
  • Patient is ≥ 18 years of age.
  • Both men and women of all races and ethnic groups are eligible for this trial.
  • Performance Status ≤ ECOG 3
  • Patient is able to gargle and spit 5 cc of saline
  • Patients may be concurrently enrolled in other therapeutic or detection clinical trials

You CAN'T join if...

  • Prior completed therapy for an upper aerodigestive tract cancer within the past 3 years.
  • Patient unable to gargle and spit 5 cc of saline, or anticipated to be unable to gargle and spit after completion of therapy
  • Patient unable or does not intend to undergo curative therapy
  • Patient with concurrent, second primary malignancy under active therapy or completed therapy within 2 years prior to enrollment.

Locations

  • UCSD Moores Cancer Center accepting new patients
    La Jolla California 92093 United States
  • Greater Baltimore Medical Center accepting new patients
    Baltimore Maryland 21204 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Joseph Califano
ID
NCT03148665
Lead Scientist
Joseph Califano
Study Type
Interventional
Last Updated