Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00899704
Recruitment Status : Withdrawn (Study was never published)
First Posted : May 12, 2009
Last Update Posted : January 30, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Tracking Information
First Submitted Date May 9, 2009
First Posted Date May 12, 2009
Last Update Posted Date January 30, 2019
Study Start Date March 2008
Actual Primary Completion Date March 2008   (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 Pre-specified Outcome Measures Not Provided
Original Other Pre-specified 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 Withdrawn
Actual Enrollment
 (submitted: January 29, 2019)
0
Original Estimated Enrollment
 (submitted: May 9, 2009)
161
Actual Study Completion Date March 2008
Actual Primary Completion Date March 2008   (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 information is only displayed when the study is recruiting subjects
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 January 2019