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

Molecular Mechanisms of OSCC Tumor Invasion

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00899704

Enrollment

Registered

2009-05-12

Start date

2008-03-31

Completion date

2008-03-31

Last updated

2019-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Cancer

Keywords

stage I squamous cell carcinoma of the lip and oral cavity, stage II squamous cell carcinoma of the lip and oral cavity, tongue cancer

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.

Interventions

GENETICmicroarray analysis

GENETICallele-specific oligonucleotide real-time quantitative polymerase chain reaction

OTHERdiagnostic laboratory biomarker analysis

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion 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)

Design outcomes

Primary

Measure	Time frame
overall survival	Up to 5 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026