Bluestone Trials

Detect 44

Saliva-based detection test for presence of disease in untreated oral cancer
Status: Currently recruiting subjects.

Saliva-based detection test for presence of disease in untreated oral cancer

The purpose of this study is to test the ability of OncAlert oral rinse device to screen for oral/oropharyngeal cancer and the reappearance of oral/oropharyngeal cancer. Understanding the performance of the OncAlert oral rinse device may help doctors provide better screening exam for detection of oral cancer at early stage. This study will compare the detection of oral cancer from oral rinse with saliva in oral cancer and healthy volunteers.

Study Details:

Oral and oropharyngeal cancer is a significant health issue and has high mortality and morbidity. Unfortunately, most oral cancer cases are diagnosed in late stage with a 5-year survival rate around 30-40%. The current “gold standard” for oral and oropharyngeal cancers diagnosis is a physical and visual examination followed by a biopsy. However, there is an unmet need for a test that will improve or enhance risk assessment for oral cancer.

You may be eligible to participate in this study if you have been recently diagnosed with oral cancer with no previous treatment, are at least 18 years of age, no concurrent second active cancer and plans to undergo curative treatment. Research subject must be willing to stay enrolled for the duration of the study.

For patients diagnosed with oral cancer, this study consists of 5 visits over a period of 5 years.  It involves one visit before your treatment, and 4 follow up visits (3 months, 6 months, 12 months and 18 months) after your completion of cancer treatment. During the first visit, we will make sure you are eligible to participate in the study and ask you to complete some study procedures, such as vitals, physical examination, and collection of your mouth rinse sample. After the 4 follow up visits, we will continue to follow up with you and collect information from your medical records for 3 more years.

Interested in participating?

If you, a family member, or someone you know is interested in this study, please contact our clinical research coordinator Hanting Liang at 212-992-7014 or Or, fill out our contact form. We will get back to you as soon as possible. Confidentiality will be maintained for all applicants and participants.