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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Oral Cavity Squamous Cell Carcinoma
- Sponsor
- Joseph Califano
- Enrollment
- 85
- Locations
- 4
- Primary Endpoint
- To validate performance of the Vigilant Oral Rinse Point of Care strip in a multi-institutional clinical setting
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief 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.
Detailed Description
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
Investigators
Joseph Califano
Study Chair
University of California, San Diego
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
To validate performance of the Vigilant Oral Rinse Point of Care strip in a multi-institutional clinical setting
Time Frame: 4 years
* The agreement between CD44 ELISA and BCA test as measured using the POC test (OncAlert) and central laboratory testing at Vigilant The concordance of these two measures will be assessed using Cohen's kappa statistic for a dichotomized outcome (positive vs. negative test). A kappa of 0.6 or lower will be considered of insufficient concordance, and the minimum required level indicating adequate concordance is a kappa of 0.8 * The sensitivity and specificity of the OncAlert test to detect OOPSCC in cases compared to a non cancer control population. * A specificity of 0.65 minimally acceptable for the Vigilant POC test. In order to demonstrate a clinically acceptable level of specificity, a performance goal of 0.75 is chosen
Secondary Outcomes
- To prospectively validate the performance of pretreatment Vigilant Oral Rinse Point of Care strip and Sol CD44 as a predictor of outcome for oral/oropharyngeal cancer in a point of care multi-institutional clinical setting(4 years)
- To determine the association of post treatment salivary solCD44 and the Vigilant Oral Rinse Point of Care strip with disease outcome in oral/oropharyngeal cancer(4 years)