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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

49 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-11-30

Study Completion Date

2011-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Head and Neck Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Head and neck squamous cell carcinoma patients (HNSCC)

DNA Microarray analysis

Intervention Type GENETIC

Tumors will be assayed on Affymetrix Human Genome U133 GeneChip

MALDI-TOF mass spectrometry

Intervention Type GENETIC

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.

DNA microarray and MALDI-TOF mass spectrometry

Intervention Type GENETIC

Tumors from the specific Aim 1/2 and from preliminary data, previously analyzed, will be examined for HPV 16 infection.

Interventions

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DNA Microarray analysis

Tumors will be assayed on Affymetrix Human Genome U133 GeneChip

Intervention Type 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.

Intervention Type 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.

Intervention Type GENETIC

Eligibility Criteria

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Inclusion 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

Eligible Sex

ALL

Accepts Healthy Volunteers

No