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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 21 August 2017
Main ID:  NCT03239834
Date of registration: 19/06/2017
Prospective Registration: Yes
Primary sponsor: Vigilant Biosciences, Inc.
Public title: Clinical Evaluation of the OncAlert RAPID in Subjects Presenting for Evaluation and/or Initial Biopsy; Impact on Decision-Making
Scientific title: Clinical Evaluation of the OncAlert RAPID; Impact on Decision-Making
Date of first enrolment: March 31, 2017
Target sample size: 1000
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT03239834
Study type:  Observational
Study design:   
Phase:  N/A
Countries of recruitment
United States
Contacts
Name:   J Britt, M.D.
Address: 
Telephone:
Email:
Affiliation: 
Name:   Michael Donovan, PhD, MD
Address: 
Telephone: 954-555-1212
Email: michael.donovan@vigilantbiosciences.com
Affiliation: 
Key inclusion & exclusion criteria

Inclusion Criteria:

- 23 years of age or older

- A clinical suspicion of oral potentially malignant disorders, oral or oropharyngeal
cancer, or both based in part on clinical examination, symptoms, clinical history,
suspicious lesion(s) in mouth without history of a prior biopsy.

- The subject must be able to comprehend and sign an approved informed consent form and
other applicable study documents. Patients are eligible regardless of race, gender,
and ethnicity.

Exclusion Criteria:

- Prior history and/or diagnosis of any HN cancer/HNSCC of the oral cavity, oropharynx,
or hypopharynx including nasopharyngeal carcinoma.

- Prior treatment of HN cancer / HNSCC of the oral cavity, oropharynx, or hypopharynx
including nasopharyngeal carcinoma.

- Planned excisional biopsy for a diagnosis of HNSCC

- Clinical presentation without localizing findings

- Prior history of a salivary gland tumor

- Current and or prior diagnosis of cancer (note: other than basal and squamous cell
carcinoma of the skin) within the past 5 years.

- Pregnant



Age minimum: 23 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Gingival Neoplasms
Leukoplakia, Oral
Lip Neoplasm
Oral Ulcer
Oropharyngeal Neoplasms
Palatal Neoplasms
Tongue Neoplasms
Intervention(s)
Device: OncAlert
Primary Outcome(s)
Association of RAPID results with oral cavity / oropharyngeal biopsy. [Time Frame: 18 months]
Association of RAPID results with the clinical decision process for avoiding an immediate biopsy. [Time Frame: 18 months]
Secondary Outcome(s)
Secondary ID(s)
VIG-001
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Pearl Pathways
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