Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oral Cavity Squamous Cell Carcinoma | Oral Cavity Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Oropharynx Squamous Cell Carcinoma | Oropharynx Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Squamous Cell Carcinoma of the Head and Neck | Head and Neck Squamous Cell Carcinoma | ALIAS | 0.90 |
| Squamous Cell Carcinoma of the Oropharynx | Oropharyngeal Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| OncAlert | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- 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
- interventionNames
- Device: OncAlert
- label
- 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
- interventionNames
- Device: OncAlert
Primary outcomes (1)
- measure
- To validate performance of the Vigilant Oral Rinse Point of Care strip in a multi-institutional clinical setting
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDFranzmann EJ, Qi Y, Peifer S, Messer K, Messing B, Blanco RG, Khan Z, Fahkry C, Coffey C, Califano J 3rd. Salivary CD44 and Total Protein Levels to Detect Risk for Oral and Oropharyngeal Cancer Recurrence: A Nonrandomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2024 Oct 1;150(10):843-850. doi: 10.1001/jamaoto.2024.2490. PMID 39145961