ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 15 of 2127 for:    Oral Cancer | NIH

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Recruitment Status : Withdrawn (Study was never published)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

May 9, 2009
May 12, 2009
January 30, 2019
March 2008
March 2008   (Final data collection date for primary outcome measure)
overall survival [ Time Frame: Up to 5 years ]
  • Predictive ability of node-positive OSCC signature
  • Lymph node predictions using sentinel lymph nodes
  • Validation of preliminary data
Complete list of historical versions of study NCT00899704 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Biomarkers in Tissue Samples From Patients Who Have Undergone Neck Dissection for Oral Cancer
Molecular Mechanisms of OSCC Tumor Invasion

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Retrospective
Not Provided
Not Provided
Probability Sample
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
Head and Neck Cancer
  • 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
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
161
March 2008
March 2008   (Final data collection date for primary outcome measure)
  • 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)
Sexes Eligible for Study: All
Child, Adult, Older Adult
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00899704
ACOSOG-Z3081
ACOSOG-Z3081
CDR0000589332 ( Registry Identifier: NCI Physician Data Query )
No
Not Provided
Not Provided
Alliance for Clinical Trials in Oncology
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Study Chair: Barry Ziober, PhD Abramson Cancer Center of the University of Pennsylvania
Alliance for Clinical Trials in Oncology
January 2019