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Biomarkers in Predicting Response to Treatment in Patients With Newly Diagnosed Stage III or Stage IV Head and Neck Cancer Treated With Carboplatin, Paclitaxel, and Radiation Therapy

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: NCT00898430
Recruitment Status : Terminated (Study closed prematurely upon PI's departure)
First Posted : May 12, 2009
Last Update Posted : April 2, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Barbara Murphy, MD, Vanderbilt-Ingram Cancer Center

Tracking Information
First Submitted Date May 9, 2009
First Posted Date May 12, 2009
Last Update Posted Date April 2, 2013
Study Start Date November 2003
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 29, 2013)
Survival [ Time Frame: at expiration of last patient enrolled ]
Original Primary Outcome Measures
 (submitted: May 9, 2009)
Survival
Change History
Current Secondary Outcome Measures
 (submitted: March 29, 2013)
Treatment response [ Time Frame: upon patient tissue collection ]
Original Secondary Outcome Measures
 (submitted: May 9, 2009)
Treatment response
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Biomarkers in Predicting Response to Treatment in Patients With Newly Diagnosed Stage III or Stage IV Head and Neck Cancer Treated With Carboplatin, Paclitaxel, and Radiation Therapy
Official Title Biomarkers of Survival in HNSCC
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. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This research study is looking at biomarkers in predicting response to treatment in patients with newly diagnosed stage III or stage IV head and neck cancer treated with carboplatin, paclitaxel, and radiation therapy.

Detailed Description

OBJECTIVES:

  • Determine if gene expression patterns that correlate with treatment response and survival can be identified using DNA microarrays in patients with newly diagnosed head and neck squamous cell carcinoma (HNSCC) treated with carboplatin, paclitaxel, and radiotherapy.
  • Determine if protein expression patterns that correlate with treatment response and survival in HNSCC can be identified using matrix-assisted laser desorption ionization-time-of-flight mass spectrometry (MALDI-TOFMS).
  • Determine if the molecular signature of human papilloma virus-16 infection can be determined using DNA microarray and MALDI-TOFMS and correlate with gene and protein expression, treatment response, and survival.

OUTLINE: Tumor tissue samples are analyzed by DNA microarray analysis and validated by quantitative reverse transcription-polymerase chain reaction (PCR). Protein and gene expression patterns are analyzed by laser desorption ionization-time-of-flight mass spectrometry, high performance liquid chromatography, liquid chromatography-tandem mass spectrometry, and PCR. Samples are also analyzed by tissue microarray and immunohistochemistry.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Head and Neck cancer patients who are uniformly treated with concurrent carboplatin/paclitaxel and radiation.
Condition Head and Neck Cancer
Intervention
  • Genetic: DNA Microarray analysis
    Tumors will be assayed on Affymetrix Human Genome U133 GeneChip
  • Genetic: MALDI-TOF mass spectrometry
    Supervised analysis techniques will be employed to identify patterns of protein peaks useful for treatment response and survival prediction. Hierarchical clustering analyses will be used to visualize data.
  • Genetic: DNA microarray and MALDI-TOF mass spectrometry
    Tumors from the specific Aim 1/2 and from preliminary data, previously analyzed, will be examined for HPV 16 infection.
Study Groups/Cohorts Head and neck squamous cell carcinoma patients (HNSCC)
Interventions:
  • Genetic: DNA Microarray analysis
  • Genetic: MALDI-TOF mass spectrometry
  • Genetic: DNA microarray and MALDI-TOF mass spectrometry
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 Terminated
Actual Enrollment
 (submitted: March 23, 2011)
49
Original Enrollment Not Provided
Actual Study Completion Date February 2011
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

DISEASE CHARACTERISTICS:

  • Newly diagnosed head and neck squamous cell carcinoma

    • Stage III-IV disease
  • Scheduled for pan-endoscopy
  • Tumor tissue available from patients treated with carboplatin, paclitaxel, and radiotherapy on protocol VU-VICC-HN-0356

PATIENT CHARACTERISTICS:

  • Able to speak English

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
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 NCT00898430
Other Study ID Numbers VICC HN 0392
P30CA068485 ( U.S. NIH Grant/Contract )
VU-VICC-HN-0392
VU-VICC-030933
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Barbara Murphy, MD, Vanderbilt-Ingram Cancer Center
Study Sponsor Vanderbilt-Ingram Cancer Center
Collaborators National Cancer Institute (NCI)
Investigators
Study Chair: Barbara Murphy, MD Vanderbilt-Ingram Cancer Center
PRS Account Vanderbilt-Ingram Cancer Center
Verification Date March 2013