Biomarkers in Tissue Samples From Patients Who Have Undergone Neck Dissection for Oral Cancer
NCT ID: NCT00899704
Last Updated: 2019-01-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
2008-03-31
2008-03-31
Brief Summary
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PURPOSE: This research study is looking at tissue samples in predicting oral cancer in patients who have undergone neck dissection for oral cancer.
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Detailed Description
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* 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.
Conditions
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Study Design
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CASE_ONLY
RETROSPECTIVE
Study Groups
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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.
microarray analysis
allele-specific oligonucleotide real-time quantitative polymerase chain reaction
diagnostic laboratory biomarker analysis
Interventions
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microarray analysis
allele-specific oligonucleotide real-time quantitative polymerase chain reaction
diagnostic laboratory biomarker analysis
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
\* 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)
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
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Principal Investigators
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Barry Ziober, PhD
Role: STUDY_CHAIR
Abramson Cancer Center at Penn Medicine
Locations
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Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Countries
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Other Identifiers
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ACOSOG-Z3081
Identifier Type: -
Identifier Source: secondary_id
CDR0000589332
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACOSOG-Z3081
Identifier Type: -
Identifier Source: org_study_id
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