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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01587573
Other study ID # PeriRx-1
Secondary ID
Status Recruiting
Phase
First received April 26, 2012
Last updated April 10, 2018
Start date April 2012
Est. completion date December 2018

Study information

Verified date May 2017
Source PeriRx
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 370
Est. completion date December 2018
Est. primary completion date September 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Other:
saliva collection prior to clinically driven oral biopsy
cell free saliva to be used to measure mRNA and proteins by PCR and ELISA

Locations

Country Name City State
United States University of Michigan Ann Arbor Michigan
United States University of Illinois at Chicago Chicago Illinois
United States Department of Surgery, Michigan Sate University East Lansing Michigan
United States St. John Providence Health System Warren Michigan
United States Main Line Health System Wynnewood Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
PeriRx

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Test specificity at 90% sensitivity Based on multimarker test score at study completion as well as after model development following enrollment of the first 30 patents with cancer
Secondary Validation of individual mRNA and protein markers Based on comparison of cancer and controls After enrollment of 30 patients with cancer
Secondary Validation of a pre-specified multi marker model Based on combined sensitivity and specificity After enrollment of 30 patients with cancer
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