Biomarkers in Tissue Samples From Patients Who Have Undergone Neck Dissection for Oral Cancer

Tracking Information
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; (submitted: July 23, 2015)	overall survival [ Time Frame: Up to 5 years ]
Original Primary Outcome Measures; (submitted: May 9, 2009)	Predictive ability of node-positive OSCC signature; Lymph node predictions using sentinel lymph nodes; Validation of preliminary data
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.
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	Observational
Study Design	Observational Model: Case-Only; Time Perspective: Retrospective
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	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
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: Genetic: microarray analysis; Genetic: allele-specific oligonucleotide real-time quantitative polymerase chain reaction; Other: diagnostic laboratory biomarker analysis
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Recruiting
Estimated Enrollment; (submitted: May 9, 2009)	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	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)
Sex/Gender	Sexes Eligible for Study: All
Ages	Child, Adult, Older Adult
Accepts Healthy Volunteers	No
Contacts	Contact: Barry Ziober, PhD (215) 898-0075
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 )
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	Study Chair: Barry Ziober, PhD Abramson Cancer Center of the University of Pennsylvania
PRS Account	Alliance for Clinical Trials in Oncology
Verification Date	August 2017