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Trial record 15 of 2089 for:    Oral Cancer | NIH

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
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

May 9, 2009
May 12, 2009
August 8, 2017
March 2008
January 2100   (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
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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
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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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
161
Same as current
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January 2100   (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: Barry Ziober, PhD (215) 898-0075
United States
 
 
NCT00899704
ACOSOG-Z3081
ACOSOG-Z3081
CDR0000589332 ( Registry Identifier: NCI Physician Data Query )
No
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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
August 2017