Head and Neck CancerNCT00898430
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
An observational study of Head and Neck Cancer, run by Vanderbilt-Ingram Cancer Center at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- DNA Microarray analysis, MALDI-TOF mass spectrometry and DNA microarray and MALDI-TOF mass spectrometry
- How many people
- 49 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2003to Feb 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Head and Neck cancer patients who are uniformly treated with concurrent carboplatin/paclitaxel and radiation.
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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville, Tennessee, 37064
Vanderbilt-Ingram Cancer Center at Franklin
Nashville, Tennessee, 37064
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838
About this study
Official title: Biomarkers of Survival in HNSCC
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.
Read the 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.
- Conditions
- Head and Neck Cancer
- Being tested
- DNA Microarray analysis, MALDI-TOF mass spectrometry, DNA microarray and MALDI-TOF mass spectrometry
- Keywords
- stage III squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the larynx, stage III verrucous carcinoma of the larynx, stage IV squamous cell carcinoma of the larynx, stage IV verrucous carcinoma of the larynx, stage III squamous cell carcinoma of the lip and oral cavity, stage IV squamous cell carcinoma of the lip and oral cavity, stage III verrucous carcinoma of the oral cavity, stage IV verrucous carcinoma of the oral cavity, metastatic squamous neck cancer with occult primary squamous cell carcinoma, untreated metastatic squamous neck cancer with occult primary, stage III squamous cell carcinoma of the nasopharynx, stage IV squamous cell carcinoma of the nasopharynx, stage III squamous cell carcinoma of the oropharynx, stage IV squamous cell carcinoma of the oropharynx, stage III squamous cell carcinoma of the paranasal sinus and nasal cavity, stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity, salivary gland squamous cell carcinoma, stage III salivary gland cancer
- Medical subject headings
- Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck, Salivary Gland Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNA Microarray analysisGenetic
Tumors will be assayed on Affymetrix Human Genome U133 GeneChip
MALDI-TOF mass spectrometryGenetic
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 spectrometryGenetic
Tumors from the specific Aim 1/2 and from preliminary data, previously analyzed, will be examined for HPV 16 infection.
| Study group | Role | What they receive |
|---|---|---|
| Head and neck squamous cell carcinoma patients (HNSCC) | Not described Receives: Genetic: DNA Microarray analysis; Genetic: MALDI-TOF mass spectrometry; Genetic: DNA microarray and MALDI-TOF mass spectrometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Measured: at expiration of last patient enrolled
Secondary outcomes (1)
Treatment response
Measured: upon patient tissue collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startNov 2003
- Primary completionFeb 2011
- Study completionFeb 2011
Why it stopped: Study closed prematurely upon PI's departure
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Barbara Murphy, MD, Vanderbilt-Ingram Cancer Center
- Investigators
- Barbara Murphy, MD, Study chair, Vanderbilt-Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00898430
- Sponsor's protocol ID
- VICC HN 0392
- Other IDs
- P30CA068485, VU-VICC-HN-0392, VU-VICC-030933
- Status last verified
- Mar 2013
- First submitted
- 9 May 2009
- Last updated
- 2 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers of Survival in HNSCC
- ClinicalTrials.gov ID
- NCT00898430
- Acronym / sponsor ID
- VICC HN 0392
- Conditions
- Head and Neck Cancer
- Keywords
- stage III squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the larynx, stage III verrucous carcinoma of the larynx, stage IV squamous cell carcinoma of the larynx, stage IV verrucous carcinoma of the larynx, stage III squamous cell carcinoma of the lip and oral cavity, stage IV squamous cell carcinoma of the lip and oral cavity
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study closed prematurely upon PI's departure
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Vanderbilt-Ingram Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Nov 2003
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 12 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Head and neck squamous cell carcinoma patients (HNSCC) | – | Genetic: DNA Microarray analysis, Genetic: MALDI-TOF mass spectrometry, Genetic: DNA microarray and MALDI-TOF mass spectrometry |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Head and Neck cancer patients who are uniformly treated with concurrent carboplatin/paclitaxel and radiation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DNA Microarray analysisTumors will be assayed on Affymetrix Human Genome U133 GeneChip | Genetic | Head and neck squamous cell carcinoma patients (HNSCC) |
| MALDI-TOF mass spectrometrySupervised 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 | Head and neck squamous cell carcinoma patients (HNSCC) |
| DNA microarray and MALDI-TOF mass spectrometryTumors from the specific Aim 1/2 and from preliminary data, previously analyzed, will be examined for HPV 16 infection. | Genetic | Head and neck squamous cell carcinoma patients (HNSCC) |
Primary outcome
Survival
Time frame: at expiration of last patient enrolled
1 secondary outcome
Treatment response
Time frame: upon patient tissue collection
Results and safety
The study was stopped early (reason given: Study closed prematurely upon PI's departure). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara Murphy, MD study chair
Vanderbilt-Ingram Cancer Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Cancer, run by Vanderbilt-Ingram Cancer Center at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study closed prematurely upon PI's departure). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival (time frame: at expiration of last patient enrolled). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2013.