Saliva-based Detection of CD44 (Detect 44)

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

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.

Study Overview

• Status: Completed
• Conditions: Squamous Cell Carcinoma of the Head and Neck; Oropharynx Squamous Cell Carcinoma; Oral Cavity Squamous Cell Carcinoma; Squamous Cell Carcinoma of the Oropharynx
• Intervention / Treatment: Device: OncAlert

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

• Study Type: Observational
• Enrollment (Actual): 85

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92093
      • UCSD Moores Cancer Center
  • Maryland
    • Baltimore, Maryland, United States, 21204
      • Greater Baltimore Medical Center
    • Baltimore, Maryland, United States, 21231
      • Johns Hopkins School of Medicine
  • New York
    • New York, New York, United States, 10010
      • New York University College of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Cancer patients were identified through tumor board. Control patients were identified by referral.

Description

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.
• 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

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control population; Control population (n=150): absence of current or prior oropharyngeal carcinoma, no active cancer diagnosis. Control population includes at least 50 subjects who have smoked at least 100 cigarettes during lifetime OncAlert saliva-based screening, a noninvasive point of care salivary rinse test performed as a one-time test for control subjects	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
Cancer population; Cancer population (n=150): patients with previously untreated oral cavity or oropharynx squamous cell carcinoma with absence of distant metastasis OncAlert saliva-based screening, a noninvasive point of care salivary rinse test performed as at pretreatment and post treatment 3,6, 12, and 18 month time points in oral cavity/oropharynx cancer patients	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To validate performance of the Vigilant Oral Rinse Point of Care strip in a multi-institutional clinical setting	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	4 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	- The association of salivary CD44 POC test biomarkers, including both the POC test and quantitative ELISA based assay with clinical characteristics of OOPSCC patients, such as site, stage, treatment, smoking, alcohol, HPV status, and patient overall and disease free survival using univariate and multivariate analyses.	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	- The association of salivary CD44 POC test biomarkers, including both the POC test and quantitative ELISA based assay with recurrence of OSCC in an OSCC population with clinical characteristics of OOPSCC patients, such as site, stage, treatment, smoking, alcohol, HPV status, and patient overall and disease free survival using univariate and multivariate analyses and determine the magnitude of that association.	4 years

Collaborators and Investigators

• Sponsor: Joseph Califano
• Collaborators: Johns Hopkins University; NYU Langone Health; Greater Baltimore Medical Center; San Diego Veterans Healthcare System; Vigilant Biosciences, Inc.
• Investigators: Study Chair: Joseph Califano, MD, University of California, San Diego

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 14, 2017
• Primary Completion (ACTUAL): April 10, 2019
• Study Completion (ACTUAL): May 3, 2022

Study Registration Dates

• First Submitted: May 4, 2017
• First Submitted That Met QC Criteria: May 8, 2017
• First Posted (ACTUAL): May 11, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 17, 2022
• Last Update Submitted That Met QC Criteria: August 16, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Head and Neck Cancer; Oral Cancer
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Head and Neck Neoplasms; Neoplasms, Squamous Cell; Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
• Other Study ID Numbers: 161215

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes