- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00899704
Biomarkers in Tissue Samples From Patients Who Have Undergone Neck Dissection for Oral Cancer
Molecular Mechanisms of OSCC Tumor Invasion
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.
Study Overview
Status
Conditions
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 Type
Contacts and Locations
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104-4283
- Abramson Cancer Center of the University of Pennsylvania
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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)
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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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.
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Other Names:
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
overall survival
Time Frame: Up to 5 years
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Up to 5 years
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Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Barry Ziober, PhD, Abramson Cancer Center of the University of Pennsylvania
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ACOSOG-Z3081
- CDR0000589332 (Registry Identifier: NCI Physician Data Query)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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