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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00899704
First received: May 9, 2009
Last updated: February 26, 2011
Last verified: June 2008
  Purpose

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 Intervention
Head and Neck Cancer
Genetic: microarray analysis
Genetic: polymerase chain reaction
Other: laboratory biomarker analysis

Study Type: Observational
Official Title: Molecular Mechanisms of OSCC Tumor Invasion

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Predictive ability of node-positive OSCC signature [ Designated as safety issue: No ]
  • Lymph node predictions using sentinel lymph nodes [ Designated as safety issue: No ]
  • Validation of preliminary data [ Designated as safety issue: No ]

Estimated Enrollment: 161
Study Start Date: March 2008
Estimated Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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)

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00899704

Sponsors and Collaborators
American College of Surgeons
Investigators
Study Chair: Barry L. Ziober, PhD Abramson Cancer Center of the University of Pennsylvania
Investigator: Gregory S. Weinstein, MD, FACS Abramson Cancer Center of the University of Pennsylvania
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00899704     History of Changes
Other Study ID Numbers: CDR0000589332, ACOSOG-Z3081
Study First Received: May 9, 2009
Last Updated: February 26, 2011
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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
Neoplasms by Site
Neoplasms

ClinicalTrials.gov processed this record on September 18, 2014