Developing an In-vitro Diagnostic Risk-Stratification Test for Oral Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by PeriRx
Sponsor:
Information provided by (Responsible Party):
PeriRx
ClinicalTrials.gov Identifier:
NCT01587573
First received: April 26, 2012
Last updated: September 28, 2014
Last verified: September 2014

April 26, 2012
September 28, 2014
April 2012
December 2014   (final data collection date for primary outcome measure)
Test specificity at 90% sensitivity [ Time Frame: at study completion ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT01587573 on ClinicalTrials.gov Archive Site
  • Validation of individual mRNA and protein markers [ Time Frame: After enrollment of 30 patients with cancer ] [ Designated as safety issue: No ]
  • Validation of a pre-specified multi marker model [ Time Frame: After enrollment of 30 patients with cancer ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Developing an In-vitro Diagnostic Risk-Stratification Test for Oral Cancer
Pivotal Validation Study of Salivary Biomarkers for the Risk Stratification of Patients With Lesions Suspicious for Oral Squamous Cell Carcinoma

The purpose of this study is to verify the discriminatory value of previously identified salivary transcriptome and proteome markers for oral squamous cell cancer in an intended use population of patients with oral lesions suspicious for cancer.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

cell free saliva

Non-Probability Sample

patients with oral lesions suspicious for squamous cell cancer and scheduled for clinically driven biopsy

Oral Squamous Cell Carcinoma
Other: saliva collection prior to clinically driven oral biopsy
cell free saliva to be used to measure mRNA and proteins by PCR and ELISA
oral lesions
oral lesions suspicious for squamous cell carcinoma with saliva collection prior to clinically driven oral biopsy
Intervention: Other: saliva collection prior to clinically driven oral biopsy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
370
December 2014
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients scheduled for biopsy of an oral lesion suspicious for squamous cell cancer

Exclusion Criteria:

  • Patients with known prior oral malignancy in last 2 years or other cancer in last 5 years other than non melanoma skin cancer or with immune deficiency
Both
18 Years and older
No
United States
 
NCT01587573
PeriRx-1
Yes
PeriRx
PeriRx
Not Provided
Principal Investigator: Barry Wenig, MD University of Illinois at Chicago
Study Chair: Joseph I Helman, DMD University Michigan
PeriRx
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP