Saliva-based Detection of CD44

NCT ID: NCT03148665

Last Updated: 2022-08-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 85 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-04-14
• Study Completion Date: 2022-05-03

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

Conditions

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Control population

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

OncAlert

Intervention Type: DEVICE

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

Cancer population

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

OncAlert

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vigilant Biosciences, Inc.

INDUSTRY

Sponsor Role: collaborator

Greater Baltimore Medical Center

OTHER

Sponsor Role: collaborator

San Diego Veterans Healthcare System

FED

Sponsor Role: collaborator

NYU Langone Health

OTHER

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: collaborator

Joseph Califano

OTHER

Sponsor Role: lead

Responsible Party

Joseph Califano

Study Chair

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Joseph Califano, MD

Role: STUDY_CHAIR

University of California, San Diego

Locations

UCSD Moores Cancer Center

La Jolla, California, United States

Greater Baltimore Medical Center

Baltimore, Maryland, United States

Johns Hopkins School of Medicine

Baltimore, Maryland, United States

New York University College of Dentistry

New York, New York, United States

Countries

United States

References

Franzmann 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.

Reference Type: DERIVED

PMID: 39145961 (View on PubMed)

Other Identifiers

161215

Identifier Type: -

Identifier Source: org_study_id