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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Tracking Information | |||||
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First Submitted Date | May 9, 2009 | ||||
First Posted Date | May 12, 2009 | ||||
Last Update Posted Date | August 8, 2017 | ||||
Study Start Date | March 2008 | ||||
Estimated Primary Completion Date | January 2100 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
overall survival [ Time Frame: Up to 5 years ] | ||||
Original Primary Outcome Measures |
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Change History | Complete list of historical versions of study NCT00899704 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures | Not Provided | ||||
Original Secondary Outcome Measures | Not Provided | ||||
Current Other Outcome Measures | Not Provided | ||||
Original Other Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | Biomarkers in Tissue Samples From Patients Who Have Undergone Neck Dissection for Oral Cancer | ||||
Official Title | Molecular Mechanisms of OSCC Tumor Invasion | ||||
Brief Summary | 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. |
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Detailed Description | OBJECTIVES:
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. |
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Study Type | Observational | ||||
Study Design | Observational Model: Case-Only Time Perspective: Retrospective |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
Sampling Method | Probability Sample | ||||
Study Population | 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. are | ||||
Condition | Head and Neck Cancer | ||||
Intervention |
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Study Groups/Cohorts | 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.
Interventions:
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Recruiting | ||||
Estimated Enrollment |
161 | ||||
Original Estimated Enrollment | Same as current | ||||
Study Completion Date | Not Provided | ||||
Estimated Primary Completion Date | January 2100 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria |
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Sex/Gender |
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Ages | Child, Adult, Senior | ||||
Accepts Healthy Volunteers | No | ||||
Contacts |
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Listed Location Countries | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT00899704 | ||||
Other Study ID Numbers | ACOSOG-Z3081 ACOSOG-Z3081 CDR0000589332 ( Registry Identifier: NCI Physician Data Query ) |
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Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product | Not Provided | ||||
IPD Sharing Statement | Not Provided | ||||
Responsible Party | Alliance for Clinical Trials in Oncology | ||||
Study Sponsor | Alliance for Clinical Trials in Oncology | ||||
Collaborators | National Cancer Institute (NCI) | ||||
Investigators |
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PRS Account | Alliance for Clinical Trials in Oncology | ||||
Verification Date | August 2017 |