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

Alliance for Clinical Trials in Oncology

Status: Withdrawn

Conditions: Head and Neck Cancer

Treatments: Genetic: allele-specific oligonucleotide real-time quantitative polymerase chain reaction; Other: diagnostic laboratory biomarker analysis; Genetic: microarray analysis

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00899704

CDR0000589332 (Registry Identifier)

ACOSOG-Z3081

Details and patient eligibility

About

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.

Full 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.

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• Have a primary tumor specimen banked by the American College of Surgeons Oncology Group (ACOSOG) as part of clinical trial ACOSOG-Z0360

  * All tumor specimens are squamous cell carcinomas of the tongue, floor of the mouth, or gingiva

• All patients have undergone neck dissections * Pathologically confirmed nodal stage (negative or positive)

Trial design

0 participants in 1 patient group

Group 1

Description:

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.

Treatment:

Genetic: allele-specific oligonucleotide real-time quantitative polymerase chain reaction

Other: diagnostic laboratory biomarker analysis

Genetic: microarray analysis