Clinical Evaluation of the OncAlert RAPID in Subjects Presenting for Evaluation and/or Initial Biopsy; Impact on Decision-Making

CompletedOBSERVATIONAL
Enrollment

893

Participants

Timeline

Start Date

September 7, 2017

Primary Completion Date

August 24, 2020

Study Completion Date

December 20, 2020

Conditions
Palatal NeoplasmsLip NeoplasmGingival NeoplasmsLeukoplakia, OralTongue NeoplasmsOropharyngeal NeoplasmsOral Ulcer
Interventions
DEVICE

OncAlert

A noninvasive point of care salivary rinse test performed as 1) a one-time test for patients presenting with suspicion of OPMD and scheduled for biopsy and 2) a multi-administered test for patients presenting with suspicious lesions not scheduled for biopsy.

Trial Locations (26)

18017

Specialty Physician Associates, Bethlehem

21201

University of Maryland, Baltimore

27106

Piedmont Ear, Nose and Throat Associates, Winston-Salem

27710

Duke Head and Neck Surgery & Communication Services, Durham

27834

Eastern Carolina University School of Dental Medicine, Greenville

29425

Medical University of South Carolina, Charleston

33136

University of Miami Health Systems, Miami

33324

ENT of South Florida Plantation, Plantation

34607

Asclepes Research, Weeki Wachee

34952

ENT of South Florida Port St. Lucie, Port Saint Lucie

38163

University of Tennessee, Memphis

50325

Heartland Medical Research, Clive

60657

Chicago ENT, Chicago

64108

UMKC School of Dentistry, Kansas City

76063

Berkson Medical, LLC, Mansfield

76109

Fort Worth ENT, Fort Worth

84790

Chrysalis Clinical Research, St. George

90048

Tower ENT, based at Cedars Sinai Medical Center, Los Angeles

90211

Dr. Joel Epstein, Beverly Hills

91941

Biosolutions Clinical Research Center, La Mesa

92350

Loma Linda School of Dentistry, Loma Linda

95661

Sacramento ENT, Roseville

95815

Sacramento ENT, Sacramento

06030

UConn Dental Medicine, Farmington

02111

Tufts University, Boston

02215

Boston University Dental School, Boston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Pearl Pathways

UNKNOWN

lead

Vigilant Biosciences, Inc.

INDUSTRY

NCT03239834 - Clinical Evaluation of the OncAlert RAPID in Subjects Presenting for Evaluation and/or Initial Biopsy; Impact on Decision-Making | Biotech Hunter | Biotech Hunter