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

NCT01587573 | Unknown DMC

• 1 other identifier: PeriRx-1
• Study Type: observational
• Target: 370
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Oral Squamous Cell Carcinoma

Keywords

salivary biomarkers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Validation of individual mRNA and protein markers

  After enrollment of 30 patients with cancer

• Validation of a pre-specified multi marker model

  After enrollment of 30 patients with cancer

Study Arms (1)

oral lesions

oral lesions suspicious for squamous cell carcinoma with saliva collection prior to clinically driven oral biopsy

Other: saliva collection prior to clinically driven oral biopsy

Interventions

saliva collection prior to clinically driven oral biopsy OTHER

cell free saliva to be used to measure mRNA and proteins by PCR and ELISA

oral lesions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• PeriRx: lead

Study Sites (5)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

WITHDRAWN

University of Michigan

Ann Arbor, Michigan, 48109, United States

TERMINATED

Department of Surgery, Michigan Sate University

East Lansing, Michigan, 48912, United States

TERMINATED

St. John Providence Health System

Warren, Michigan, 48092, United States

RECRUITING

Main Line Health System

Wynnewood, Pennsylvania, 19096, United States

RECRUITING

Related Publications (1)

• Martin JL. Validation of Reference Genes for Oral Cancer Detection Panels in a Prospective Blinded Cohort. PLoS One. 2016 Jul 13;11(7):e0158462. doi: 10.1371/journal.pone.0158462. eCollection 2016.

  PMID: 27411053 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

cell free saliva

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Study Officials

• Jack L Martin, MD

  PeriRx, LLC

  PRINCIPAL INVESTIGATOR

• Marc Surkin, MD

  Main Line Health System

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2012
• First Posted: April 30, 2012
• Study Start: April 1, 2012
• Primary Completion: September 1, 2018
• Study Completion: December 1, 2018
• Last Updated: April 12, 2018

Record last verified: 2017-05

Locations

US (5)