Biomarkers in Tissue Samples From Patients Who Have Undergone Neck Dissection for Oral Cancer
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ClinicalTrials.gov Identifier: NCT00899704 |
Recruitment Status
:
Recruiting
First Posted
: May 12, 2009
Last Update Posted
: August 8, 2017
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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 |
---|---|
Head and Neck Cancer | Genetic: microarray analysis Genetic: allele-specific oligonucleotide real-time quantitative polymerase chain reaction Other: diagnostic laboratory biomarker analysis |
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 : | Observational |
Estimated Enrollment : | 161 participants |
Observational Model: | Case-Only |
Time Perspective: | Retrospective |
Official Title: | Molecular Mechanisms of OSCC Tumor Invasion |
Study Start Date : | March 2008 |
Estimated Primary Completion Date : | January 2100 |

Group/Cohort | 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.
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Genetic: microarray analysis
Other Name: gene expression profiling
Genetic: allele-specific oligonucleotide real-time quantitative polymerase chain reaction
Other Name: ASO RQ-PCR
Other: diagnostic laboratory biomarker analysis
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- overall survival [ Time Frame: Up to 5 years ]

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Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
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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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00899704
Contact: Barry Ziober, PhD | (215) 898-0075 |
United States, Pennsylvania | |
Abramson Cancer Center of the University of Pennsylvania | Recruiting |
Philadelphia, Pennsylvania, United States, 19104-4283 | |
Contact: Barry Ziober, PhD 215-898-0075 |
Study Chair: | Barry Ziober, PhD | Abramson Cancer Center of the University of Pennsylvania |
Responsible Party: | Alliance for Clinical Trials in Oncology |
ClinicalTrials.gov Identifier: | NCT00899704 History of Changes |
Other Study ID Numbers: |
ACOSOG-Z3081 CDR0000589332 ( Registry Identifier: NCI Physician Data Query ) |
First Posted: | May 12, 2009 Key Record Dates |
Last Update Posted: | August 8, 2017 |
Last Verified: | August 2017 |
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 Neoplasms by Site Neoplasms |