Biomarkers in Tissue Samples From Patients Who Have Undergone Neck Dissection for Oral Cancer
Recruitment status was Active, not recruiting
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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 |
- 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) |
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 |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00899704
| 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 Neoplasms by Site |
ClinicalTrials.gov processed this record on February 25, 2015