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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2016 by PeriRx
Sponsor:
Information provided by (Responsible Party):
PeriRx
ClinicalTrials.gov Identifier:
NCT01587573
First received: April 26, 2012
Last updated: April 22, 2016
Last verified: April 2016

April 26, 2012
April 22, 2016
April 2012
October 2016   (final data collection date for primary outcome measure)
Test specificity at 90% sensitivity [ Time Frame: at study completion as well as after model development following enrollment of the first 30 patents with cancer ] [ 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
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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.
Saliva samples are collected from patients before clinically driven oral biopsy for lesions suspicious for cancer. Specimens are processed by laboratory personnel blinded to the tissue diagnosis. Six pre-specified mRNA markers (IL1b, IL8, SAT, DUSP1, OAZ1 and S100P) are measured by polymerase chain reaction. Markers are compared in cancer and control by raw Ct values as well as by delta Ct after adjustment for housekeeping gens. Appropriate housekeeping genes are identified in a random subset of cancer and control patients and then verified in the remaining subjects. Predictive models are generated by a pre-specified method and robustness evaluated by bootstrap analysis. The model is then further validated in a second cohort. Three pre-specified protein markers (IL8, IL1B, and M2BP) are a secondary endpoint and will also be compared in cancer and control patients.
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
November 2016
October 2016   (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   (Adult, Senior)
No
United States
 
NCT01587573
PeriRx-1
Yes
Undecided
Not Provided
PeriRx
PeriRx
Not Provided
Principal Investigator: Jack L Martin, MD PeriRx, LLC
Study Chair: Marc Surkin, MD Main Line Health System
PeriRx
April 2016

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