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

Sponsor
Alliance for Clinical Trials in Oncology (Other)
Overall Status
Withdrawn
CT.gov ID
NCT00899704
Collaborator
National Cancer Institute (NCI) (NIH)
0
Enrollment
1
Location

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Genetic: microarray analysis
  • Genetic: allele-specific oligonucleotide real-time quantitative polymerase chain reaction
  • Other: diagnostic laboratory biomarker analysis

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 Design

Study Type:
Observational
Actual Enrollment :
0 participants
Observational Model:
Case-Only
Time Perspective:
Retrospective
Official Title:
Molecular Mechanisms of OSCC Tumor Invasion
Study Start Date :
Mar 1, 2008
Actual Primary Completion Date :
Mar 1, 2008
Actual Study Completion Date :
Mar 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Group 1

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.

Genetic: microarray analysis
Other Names:
  • gene expression profiling

    • Genetic: allele-specific oligonucleotide real-time quantitative polymerase chain reaction
    Other Names:
  • ASO RQ-PCR

    • Other: diagnostic laboratory biomarker analysis

    Outcome Measures

    Primary Outcome Measures

    1. overall survival [Up to 5 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    • 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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Abramson Cancer Center of the University of Pennsylvania Philadelphia Pennsylvania United States 19104-4283

    Sponsors and Collaborators

    • Alliance for Clinical Trials in Oncology
    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: Barry Ziober, PhD, Abramson Cancer Center of the University of Pennsylvania

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Alliance for Clinical Trials in Oncology
    ClinicalTrials.gov Identifier:
    NCT00899704
    Other Study ID Numbers:
    • ACOSOG-Z3081
    • ACOSOG-Z3081
    • CDR0000589332
    First Posted:
    May 12, 2009
    Last Update Posted:
    Jan 30, 2019
    Last Verified:
    Jan 1, 2019
    Keywords provided by Alliance for Clinical Trials in Oncology
    stage I squamous cell carcinoma of the lip and oral cavity
    stage II squamous cell carcinoma of the lip and oral cavity
    tongue cancer
    Additional relevant MeSH terms:
    Head and Neck Neoplasms

    Study Results

    No Results Posted as of Jan 30, 2019