NCT03148665 (Detect 44) is a clinical trial of OncAlert in Oral Cavity Squamous Cell Carcinoma, sponsored by Joseph Califano.

Who is sponsoring NCT03148665?

NCT03148665 is sponsored by Joseph Califano.

What drugs are being tested in NCT03148665?

Interventions in NCT03148665: OncAlert.

What condition does NCT03148665 study?

NCT03148665 studies Oral Cavity Squamous Cell Carcinoma, Oropharynx Squamous Cell Carcinoma, Squamous Cell Carcinoma of the Oropharynx, Squamous Cell Carcinoma of the Head and Neck.

Is NCT03148665 still recruiting?

NCT03148665 is currently completed. Last updated 17 August 2022.

Last reviewed 2022-08-17 · How we verify

NCT03148665: Detect 44

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Saliva-based Detection of CD44

Completed Last updated 17 August 2022

What this trial tests

trial testing OncAlert in Oral Cavity Squamous Cell Carcinoma in 85 participants. Completed in 3 May 2022.

Timeline

14 April 2017

Primary endpoint
10 April 2019

3 May 2022

Quick facts

Lead sponsor	Joseph Califano
Status	Completed
Study type	OBSERVATIONAL
Enrollment	85
Start date	14 April 2017
Primary completion	10 April 2019
Estimated completion	3 May 2022
Sites	4 locations across United States

Drugs / interventions tested

OncAlert

Conditions studied

Oral Cavity Squamous Cell Carcinoma — all drugs for Oral Cavity Squamous Cell Carcinoma →
Oropharynx Squamous Cell Carcinoma — all drugs for Oropharynx Squamous Cell Carcinoma →
Squamous Cell Carcinoma of the Oropharynx — all drugs for Squamous Cell Carcinoma of the Oropharynx →
Squamous Cell Carcinoma of the Head and Neck — all drugs for Squamous Cell Carcinoma of the Head and Neck →

Sponsor

Joseph Califano

Who can join

18 and older, any sex, with Oral Cavity Squamous Cell Carcinoma or Oropharynx Squamous Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Cancer Stem Cells in Head and Neck Squamous Cell Carcinoma: Identification, Characterization and Clinical Implications.
Peitzsch C, Nathansen J, Schniewind SI, Schwarz F, et al · · 2019 · cited 61× · PMID 31052565 · DOI 10.3390/cancers11050616
Salivary CD44 and Total Protein Levels to Detect Risk for Oral and Oropharyngeal Cancer Recurrence: A Nonrandomized Clinical Trial.
Franzmann EJ, Qi Y, Peifer S, Messer K, et al · · 2024 · cited 6× · PMID 39145961 · DOI 10.1001/jamaoto.2024.2490
Cancer stem cells in head and neck cancer.
Picon H, Guddati AK. · · 2021 · cited 6× · PMID 34552815

Verify or expand the search:

Other trials of OncAlert

Trials testing the same drug.

NCT03239834 — Clinical Evaluation of the OncAlert RAPID in Subjects Presenting for Evaluation and/or Initial Biopsy; Impact on Decisio · completed

Other recruiting trials for Oral Cavity Squamous Cell Carcinoma

Currently open trials in the same condition.

NCT06980038 — Testing Whether Cemiplimab (REGN2810) Plus CDX-1140 Given Prior to Surgery Are Better Than Cemiplimab (REGN2810) Alone i · Phase 2 · recruiting
NCT07121595 — Personalized Neck Radiation Therapy Directed by Sentinel Lymph Node Biopsy for the Treatment of Oral Cavity Squamous Cel · Phase 2 · recruiting
NCT06947668 — Immune Biomarker Study for Cisplatin-ineligible Patients Receiving Chemoradiotherapy With Docetaxel · recruiting
NCT06662058 — Remote Audiometry to Monitor for Treatment-Related Hearing Loss in Patients With H&N SCC Receiving Cisplatin and/or Radi · NA · recruiting
NCT06532279 — Testing the Addition of the Drug BMX-001, a Radioprotector, or a Placebo to the Usual Chemoradiation Therapy for Patient · Phase 2 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03148665 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Joseph Califano
Last refreshed: 17 August 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03148665.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing