Biomarkers in Tissue Samples From Patients Who Have Undergone Neck Dissection for Oral Cancer - Full Text View

Purpose

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	Intervention
Head and Neck Cancer	Genetic: microarray analysis Genetic: allele-specific oligonucleotide real-time quantitative polymerase chain reaction Other: diagnostic laboratory biomarker analysis


Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Retrospective
Official Title:	Molecular Mechanisms of OSCC Tumor Invasion

Resource links provided by NLM:

Genetic and Rare Diseases Information Center resources: Tongue Cancer Oral Cancer Lip and Oral Cavity Cancer

U.S. FDA Resources

Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:

overall survival [ Time Frame: Up to 5 years ]


Estimated Enrollment:	161
Study Start Date:	March 2008
Estimated Primary Completion Date:	January 2100 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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.	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

Groups/Cohorts

Assigned Interventions

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.

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

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.

Eligibility


Ages Eligible for Study:	Child, Adult, Senior
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
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

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)

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00899704

Contacts


Contact: Barry Ziober, PhD	(215) 898-0075

Locations


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

Sponsors and Collaborators

Alliance for Clinical Trials in Oncology

National Cancer Institute (NCI)

Investigators


Study Chair:	Barry Ziober, PhD	Abramson Cancer Center of the University of Pennsylvania

More Information


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 )
Study First Received:	May 9, 2009
Last Updated:	June 24, 2016

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

ClinicalTrials.gov processed this record on June 26, 2017