Oral Cavity Squamous Cell CarcinomaDetect 44NCT03148665
Saliva-based Detection of CD44
An observational study of Oral Cavity Squamous Cell Carcinoma and Oropharynx Squamous Cell Carcinoma, run by Joseph Califano at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Oral Cavity Squamous Cell Carcinoma, Oropharynx Squamous Cell Carcinoma, Squamous Cell Carcinoma of the Oropharynx
- What is being tested?
- OncAlert
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 85 participants
- Where
- 4 sitesUnited States
- Study dates
- 14 Apr 2017to 3 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Cancer patients were identified through tumor board. Control patients were identified by referral.
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- 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 locations and contacts
4 sites in 1 country.
United States4 sites
Greater Baltimore Medical Center
Baltimore, Maryland, 21204
Johns Hopkins School of Medicine
Baltimore, Maryland, 21231
UCSD Moores Cancer Center
La Jolla, California, 92093
New York University College of Dentistry
New York, New York, 10010
About this study
Official title: 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
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.
Read the 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
- Being tested
- OncAlert
- Keywords
- Oral Cancer, Head and Neck Cancer
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Mouth Neoplasms, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OncAlertDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: OncAlert | |
| 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 Receives: Device: OncAlert |
What is being measured
The primary outcome is the main question the study is designed to answer.
To validate performance of the Vigilant Oral Rinse Point of Care strip in a multi-institutional clinical setting
- The agreement between CD44 ELISA and BCA test as measured using the POC test (OncAlert) and central laboratory testing at Vigilant The concordance of these two measures will be assessed using Cohen's kappa statistic for a dichotomized outcome (positive vs. negative test). A kappa of 0.6 or lower will be considered of insufficient concordance, and the minimum required level indicating adequate concordance is a kappa of 0.8
- The sensitivity and specificity of the OncAlert test to detect OOPSCC in cases compared to a non cancer control population.
- A specificity of 0.65 minimally acceptable for the Vigilant POC test. In order to demonstrate a clinically acceptable level of specificity, a performance goal of 0.75 is chosen
Measured: 4 years
Secondary outcomes (2)
To prospectively validate the performance of pretreatment Vigilant Oral Rinse Point of Care strip and Sol CD44 as a predictor of outcome for oral/oropharyngeal cancer in a point of care multi-institutional clinical setting
- The association of salivary CD44 POC test biomarkers, including both the POC test and quantitative ELISA based assay with clinical characteristics of OOPSCC patients, such as site, stage, treatment, smoking, alcohol, HPV status, and patient overall and disease free survival using univariate and multivariate analyses.
Measured: 4 years
To determine the association of post treatment salivary solCD44 and the Vigilant Oral Rinse Point of Care strip with disease outcome in oral/oropharyngeal cancer
- The association of salivary CD44 POC test biomarkers, including both the POC test and quantitative ELISA based assay with recurrence of OSCC in an OSCC population with clinical characteristics of OOPSCC patients, such as site, stage, treatment, smoking, alcohol, HPV status, and patient overall and disease free survival using univariate and multivariate analyses and determine the magnitude of that association.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2017
- Study start14 Apr 2017
- Primary completion10 Apr 2019
- Study completion3 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oral Cavity Squamous Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joseph Califano
- Sponsor type
- University, hospital or other
- Collaborators
- Vigilant Biosciences, Inc., Greater Baltimore Medical Center, San Diego Veterans Healthcare System, NYU Langone Health, Johns Hopkins University
- Responsible party
- Sponsor-investigator, Joseph Califano, University of California, San Diego
- Investigators
- Joseph Califano, MD, Study chair, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03148665
- Sponsor's protocol ID
- 161215
- Acronym
- Detect 44
- Status last verified
- Aug 2022
- First submitted
- 4 May 2017
- Last updated
- 17 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 39145961
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03148665
- Acronym / sponsor ID
- Detect 44 / 161215
- Conditions
- Oral Cavity Squamous Cell Carcinoma, Oropharynx Squamous Cell Carcinoma, Squamous Cell Carcinoma of the Oropharynx, Squamous Cell Carcinoma of the Head and Neck
- Keywords
- Oral Cancer, Head and Neck Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Joseph CalifanoUniversity, hospital or other
- Collaborators
- Vigilant Biosciences, Inc., Greater Baltimore Medical Center, San Diego Veterans Healthcare System, NYU Langone Health, Johns Hopkins University
- Study start
- 14 Apr 2017 (actual)
- Primary completion
- 10 Apr 2019 (actual)
- Study completion
- 3 May 2022 (actual)
- First posted
- 11 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control population | – | Device: OncAlertControl 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 |
| Cancer population | – | Device: OncAlertCancer 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Cancer patients were identified through tumor board. Control patients were identified by referral.
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OncAlertA 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 | Device | Cancer population, Control population |
Primary outcome
To validate performance of the Vigilant Oral Rinse Point of Care strip in a multi-institutional clinical setting
Time frame: 4 years
* The agreement between CD44 ELISA and BCA test as measured using the POC test (OncAlert) and central laboratory testing at Vigilant The concordance of these two measures will be assessed using Cohen's kappa statistic for a dichotomized outcome (positive vs. negative test). A kappa of 0.6 or lower will be considered of insufficient concordance, and the minimum required level indicating adequate concordance is a kappa of 0.8 * The sensitivity and specificity of the OncAlert test to detect OOPSCC in cases compared to a non cancer control population. * A specificity of 0.65 minimally acceptable for the Vigilant POC test. In order to demonstrate a clinically acceptable level of specificity, a performance goal of 0.75 is chosen
2 secondary outcomes
To prospectively validate the performance of pretreatment Vigilant Oral Rinse Point of Care strip and Sol CD44 as a predictor of outcome for oral/oropharyngeal cancer in a point of care multi-institutional clinical setting
Time frame: 4 years
To determine the association of post treatment salivary solCD44 and the Vigilant Oral Rinse Point of Care strip with disease outcome in oral/oropharyngeal cancer
Time frame: 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2022.
- Derived from this study: PubMed 39145961Franzmann 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Califano, MD study chair
University of California, San Diego
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Cavity Squamous Cell Carcinoma and Oropharynx Squamous Cell Carcinoma, run by Joseph Califano at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To validate performance of the Vigilant Oral Rinse Point of Care strip in a multi-institutional clinical setting (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03148665, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2022.