Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03148665 · ClinicalTrials.gov registry record
Saliva-based Detection of CD44
A clinical trial of Squamous Cell Carcinoma of the Head and Neck and Oral Cavity Squamous Cell Carcinoma, sponsored by Joseph Califano.
- Completed
- Registry status
- 85
- Enrollment target
- 4
- Study locations
NCT03148665: Completed study of Squamous Cell Carcinoma of the Head and Neck and Oral Cavity Squamous Cell Carcinoma, sponsored by Joseph Califano.
NCT03148665 is a study of Squamous Cell Carcinoma of the Head and Neck and Oral Cavity Squamous Cell Carcinoma that has completed, run by Joseph Califano. The registered enrollment target is 85 participants, below the 143-participant average among 29 other Squamous Cell Carcinoma of the Head and Neck trials with a reported enrollment target (41% lower). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03148665, a study of Squamous Cell Carcinoma of the Head and Neck and Oral Cavity Squamous Cell Carcinoma, has completed, sponsored by Joseph Califano.
- COMPLETED
- Registry status
- 85 participants
- Enrollment target
- 4
- Study locations
Study 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.
Primary Outcome
* 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
Conditions Studied
Interventions
- DEVICE OncAlert
Study Locations (4)
Maryland
- Greater Baltimore Medical Center - Baltimore
- Johns Hopkins School of Medicine - Baltimore
California
- UCSD Moores Cancer Center - La Jolla
New York
- New York University College of Dentistry - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 85 participants |
| Start Date | 2017-04-14 |
| Est. Completion | 2022-05-03 |
What the finished NCT03148665 record still lists
NCT03148665 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 85 participants, a relatively small participant target, below the 143-participant average among 29 other Squamous Cell Carcinoma of the Head and Neck trials with a reported enrollment target (41% lower).
The record links to 4 conditions, with Squamous Cell Carcinoma of the Head and Neck appearing as the primary indexed condition, and to 1 intervention - of which OncAlert is the first listed.
NCT03148665 reports a single indexed study location in Maryland, California, New York.
Frequently Asked Questions
What is clinical trial NCT03148665 about?
NCT03148665 is a clinical study titled "Saliva-based Detection of CD44". 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. OncAle...
What is the current status of trial NCT03148665?
This trial is currently completed. The enrollment target is 85 participants. The study started on 2017-04-14. Estimated completion is 2022-05-03.
What conditions does trial NCT03148665 study?
This clinical trial studies the following conditions: Squamous Cell Carcinoma of the Head and Neck, Oral Cavity Squamous Cell Carcinoma, Oropharynx Squamous Cell Carcinoma, Squamous Cell Carcinoma of the Oropharynx.
What interventions are being tested in trial NCT03148665?
The interventions under investigation include: OncAlert (DEVICE).
Who is sponsoring clinical trial NCT03148665?
This trial is sponsored by Joseph Califano, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03148665 being conducted?
This trial has 4 study locations across California, Maryland, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Squamous Cell Carcinoma of the Head and Neck
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03148665's enrollment target sits among peer trials
85 10th of 29 higher than 20 of 29 other Squamous Cell Carcinoma of the Head and Neck trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Squamous Cell Carcinoma of the Head and Neck trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Study of PF-08046054/SGN-PDL1V in Advanced Solid Tumors
RECRUITING · Phase 1
-
Study of Autologous Tumor Infiltrating Lymphocytes in Patients With Solid Tumors
RECRUITING · Phase 2
-
Phase II Trial of Neoadjuvant Chemotherapy (NAC) Alone or in Combination With Immunotherapy Vaccine PRGN-2009 in Subjects With Newly Diagnosed HPV-Associated Oropharyngeal (Head and Neck) Cancer
RECRUITING · Phase 2
-
Intratumoral Delivery of Viral Replicon (saRNA) Particles Expressing IL-12 in Head and Neck Cancer
RECRUITING · Phase 1
-
Study of JANX008 in Subjects With Advanced or Metastatic Solid Tumor Malignancies
RECRUITING · Phase 1
-
Phase 1a and Phase 2 Study for Safety, Preliminary Efficacy, PK and PD of ST-067
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00842283 · 85 participants
Role of Angiogenesis in Dermatologic Diseases: A Potential Therapeutic Target
- NCT02133196 · 85 participants · Phase 2
T Cell Receptor Immunotherapy for Patients With Metastatic Non-Small Cell Lung Cancer
- NCT03823144 · 85 participants · NA
Intravital Microscopy in Human Solid Tumors
- NCT03875638 · 85 participants · Phase 2
Treating Hyperexcitability in AD With Levetiracetam
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI