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Saliva-based Detection of CD44 (Detect 44)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03148665
Recruitment Status : Active, not recruiting
First Posted : May 11, 2017
Last Update Posted : June 23, 2021
Sponsor:
Collaborators:
Vigilant Biosciences, Inc.
Greater Baltimore Medical Center
San Diego Veterans Healthcare System
NYU Langone Health
Johns Hopkins University
Information provided by (Responsible Party):
Joseph Califano, University of California, San Diego

Study Description
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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.

Condition or disease Intervention/treatment
Oral Cavity Squamous Cell Carcinoma Oropharynx Squamous Cell Carcinoma Squamous Cell Carcinoma of the Oropharynx Squamous Cell Carcinoma of the Head and Neck 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 Design
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Study Type : Observational
Actual Enrollment : 85 participants
Observational Model: Case-Control
Time Perspective: Prospective
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
Actual Study Start Date : April 14, 2017
Actual Primary Completion Date : April 10, 2019
Estimated Study Completion Date : May 20, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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 [ Time Frame: 4 years ]
    - 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.

  2. 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 [ Time Frame: 4 years ]
    - 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Cancer patients were identified through tumor board. Control patients were identified by referral.
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.
  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03148665


Locations
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United States, California
UCSD Moores Cancer Center
La Jolla, California, United States, 92093
United States, Maryland
Greater Baltimore Medical Center
Baltimore, Maryland, United States, 21204
Johns Hopkins School of Medicine
Baltimore, Maryland, United States, 21231
United States, New York
New York University College of Dentistry
New York, New York, United States, 10010
Sponsors and Collaborators
Joseph Califano
Vigilant Biosciences, Inc.
Greater Baltimore Medical Center
San Diego Veterans Healthcare System
NYU Langone Health
Johns Hopkins University
Investigators
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Study Chair: Joseph Califano, MD University of California, San Diego
More Information
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Responsible Party: Joseph Califano, Study Chair, University of California, San Diego
ClinicalTrials.gov Identifier: NCT03148665    
Other Study ID Numbers: 161215
First Posted: May 11, 2017    Key Record Dates
Last Update Posted: June 23, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Joseph Califano, University of California, San Diego:
Oral Cancer
Head and Neck Cancer
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Neoplasms
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site