Saliva-based Detection of CD44 (Detect 44)

Joseph Califano

Status: Completed

Conditions: Squamous Cell Carcinoma of the Head and Neck; Squamous Cell Carcinoma of the Oropharynx; Oropharynx Squamous Cell Carcinoma; Oral Cavity Squamous Cell Carcinoma

Treatments: Device: OncAlert

Study type: Observational

Funder types: Other; Industry; Other U.S. Federal agency

Identifiers

NCT03148665

161215

Details and patient eligibility

About

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.

Full 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

Enrollment: 85 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

85 participants in 2 patient groups

Control population

Description:

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

Treatment:

Device: OncAlert

Cancer population

Description:

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

Treatment:

Device: OncAlert