Clinical trial NCT03148665: Saliva-based Detection of CD44
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oral Cavity Squamous Cell Carcinoma
Oropharynx Squamous Cell Carcinoma
Squamous Cell Carcinoma of the Oropharynx
Squamous Cell Carcinoma of the Head and Neck
Keywords: Oral Cancer
Head and Neck Cancer
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: Vigilant Biosciences, Inc.
name: Greater Baltimore Medical Center
name: San Diego Veterans Healthcare System
name: NYU Langone Health
name: Johns Hopkins University
First posted: 2017-05-11
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cancer patients were identified through tumor board. Control patients were identified by referral.

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

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.
* 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.

Primary outcomes:
measure: To validate performance of the Vigilant Oral Rinse Point of Care strip in a multi-institutional clinical setting
timeFrame: 4 years
Secondary outcomes:
measure: 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
timeFrame: 4 years
measure: 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
timeFrame: 4 years
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UCSD Moores Cancer Center
state: California
city: Baltimore
country: United States
facility: Greater Baltimore Medical Center
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins School of Medicine
state: Maryland
city: New York
country: United States
facility: New York University College of Dentistry
state: New York
Study officials:
affiliation: University of California, San Diego
name: Joseph Califano, MD
role: STUDY_CHAIR
References: