Biomarkers in Tissue Samples From Patients Who Have Undergone Neck Dissection for Oral Cancer

Withdrawn

• Conditions: Head and Neck Cancer
• Interventions: Genetic: microarray analysis; Genetic: allele-specific oligonucleotide real-time quantitative polymerase chain reaction; Other: diagnostic laboratory biomarker analysis

• Registration Number: NCT00899704
• Lead Sponsor: Alliance for Clinical Trials in Oncology

Brief Summary

RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is looking at tissue samples in predicting oral cancer in patients who have undergone neck dissection for oral cancer.

Detailed Description

OBJECTIVES:

* To test preliminary data from node-positive oral squamous cell carcinoma (OSCC) signatures for their ability to predict lymph-positive primaries using a cohort of OSCC tumors.

* To perform lymph node prediction using sentinel lymph node-biopsied primaries.

* To validate the preliminary data node-positive OSCC signature and test its ability to predict nodal status.

OUTLINE: Patient tissue samples are screened using polymerase chain reaction (PCR) for human papilloma virus-specific primers. Samples are analyzed to identify a nodal-metastasis signature for oral squamous cell carcinoma. Samples also undergo microarray analysis to quantify expression levels for targeted genes. Initial data analysis is performed using Affymetrix® Microarray Suite 5.0 to quantify expression levels for targeted genes.

Study Timeline

• Study Start: 2008-03
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Study First Submitted: 2009-05-09
• Study First Submitted QC: 2009-05-09
• Study First Posted: 2009-05-12
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-29
• Last Update Posted: 2019-01-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	microarray analysis	Patient tissue samples are screened using polymerase chain reaction (PCR) for human papilloma virus-specific primers. Samples are analyzed to identify a nodal-metastasis signature for oral squamous cell carcinoma. Samples also undergo microarray analysis to quantify expression levels for targeted genes. Initial data analysis is performed using Affymetrix® Microarray Suite 5.0 to quantify expression levels for targeted genes.
Group 1	diagnostic laboratory biomarker analysis	Patient tissue samples are screened using polymerase chain reaction (PCR) for human papilloma virus-specific primers. Samples are analyzed to identify a nodal-metastasis signature for oral squamous cell carcinoma. Samples also undergo microarray analysis to quantify expression levels for targeted genes. Initial data analysis is performed using Affymetrix® Microarray Suite 5.0 to quantify expression levels for targeted genes.
Group 1	allele-specific oligonucleotide real-time quantitative polymerase chain reaction	Patient tissue samples are screened using polymerase chain reaction (PCR) for human papilloma virus-specific primers. Samples are analyzed to identify a nodal-metastasis signature for oral squamous cell carcinoma. Samples also undergo microarray analysis to quantify expression levels for targeted genes. Initial data analysis is performed using Affymetrix® Microarray Suite 5.0 to quantify expression levels for targeted genes.

Primary Outcome Measures

Name	Time	Method
overall survival	Up to 5 years

Trial Locations

Locations (1)

Abramson Cancer Center of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States