NCT03148665

Saliva-based Detection of CD44

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 85 (actual)
• Sponsor: Joseph Califano · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Conditions

• Oral Cavity Squamous Cell Carcinoma
• Oropharynx Squamous Cell Carcinoma
• Squamous Cell Carcinoma of the Oropharynx
• Squamous Cell Carcinoma of the Head and Neck

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-04-14
• Primary completion: 2019-04-10
• Completion: 2022-05-03
• First posted: 2017-05-11
• Last updated: 2022-08-17

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study