Head and Neck CancerNCT00898664
DNA Analysis of Tissue Samples From Patients With Head and Neck Cancer
An observational study of Head and Neck Cancer, run by Vanderbilt-Ingram Cancer Center.
Trial summary
RATIONALE: Studying samples of 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 laboratory study is looking at DNA in tissue samples from patients with head and neck cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- cytogenetic analysis, gene expression analysis and mutation analysis
- How many people
- 74 participants
- Where
- No sites listed yet
- Study dates
- Jun 2006to Apr 2008
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Nonsmoking patients less than 40 years of age at first diagnosis of HNSCC.
Who may be able to join
- Patient with head and neck squamous cell carcinoma (HNSCC) enrolled in the Head and Neck Tissue Repository
- Sufficient biological material collected to perform study tests
- Historical material available from excess tissues at the Vanderbilt Pathology Department
Who cannot join
- Not specified
- PRIOR CONCURRENT THERAPY:
- Not specified
About this study
Official title: Genetic Analysis of Head and Neck Squamous Cell Carcinoma
RATIONALE: Studying samples of 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 laboratory study is looking at DNA in tissue samples from patients with head and neck cancer.
Read the detailed description
OBJECTIVES:
- Assess common genetic mutations in tumor and germline DNA samples from patients with head and neck squamous cell carcinoma (HNSCC).
- Search for viral DNAs and relate this information to demographics, tumor characteristics, and patient prognosis.
- Search for novel viral sequences and cancer-associated gene mutations in young nonsmoking HNSCC patients and in other distinct head and neck cancers.
- Determine tumor suppressor gene mutations in HNSCC patients and relate this information to gene expression data.
- Validate gene expression information using independent techniques such as real-time PCR on expressed sequences and immunohistochemistry.
OUTLINE: Genetic mutation analysis and gene expression studies are performed on tissue samples from patients with head and neck squamous cell carcinoma. Techniques used include real time-PCR and immunohistochemistry.
- Conditions
- Head and Neck Cancer
- Being tested
- cytogenetic analysis, gene expression analysis, mutation analysis, polymerase chain reaction, immunohistochemistry staining method
- Keywords
- stage I squamous cell carcinoma of the hypopharynx, stage II squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the hypopharynx, recurrent squamous cell carcinoma of the hypopharynx, stage I squamous cell carcinoma of the larynx, stage II squamous cell carcinoma of the larynx, stage III squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the larynx, recurrent squamous cell carcinoma of the larynx, stage I squamous cell carcinoma of the lip and oral cavity, stage II squamous cell carcinoma of the lip and oral cavity, stage III squamous cell carcinoma of the lip and oral cavity, stage IV squamous cell carcinoma of the lip and oral cavity, recurrent squamous cell carcinoma of the lip and oral cavity, metastatic squamous neck cancer with occult primary squamous cell carcinoma, recurrent metastatic squamous neck cancer with occult primary, untreated metastatic squamous neck cancer with occult primary, stage I squamous cell carcinoma of the nasopharynx, stage II squamous cell carcinoma of the nasopharynx
- 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.
cytogenetic analysisGenetic
gene expression analysisGenetic
mutation analysisGenetic
polymerase chain reactionGenetic
laboratory biomarker analysisOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess common genetic mutations in tumor and germline DNA samples
Measured: Upon collection of final patient data
Viral DNAs related to demographics, tumor characteristics, and patient prognosis
Measured: Upon collection of final patient data
Novel viral sequences and cancer-associated gene mutations in young nonsmoking patients with head and neck squamous cell carcinoma and in other distinct head and neck cancers
Measured: Upon collection of final patient data
Tumor suppressor gene mutations related to gene expression data
Measured: upon collection of final patient data
Validation of gene expression information using independent techniques such as real-time PCR on expressed sequences and immunohistochemistry
Measured: upon collection of final patient data
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 startJun 2006
- Primary completionApr 2008
- Study completionApr 2008
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
- 74 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
- NCT00898664
- Sponsor's protocol ID
- VICC HN 0625
- Other IDs
- VU-VICC-HN-0625, VU-VICC-IRB-060462
- 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
- Genetic Analysis of Head and Neck Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT00898664
- Acronym / sponsor ID
- VICC HN 0625
- Conditions
- Head and Neck Cancer
- Keywords
- stage I squamous cell carcinoma of the hypopharynx, stage II squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the hypopharynx, recurrent squamous cell carcinoma of the hypopharynx, stage I squamous cell carcinoma of the larynx, stage II squamous cell carcinoma of the larynx, stage III squamous cell carcinoma of the larynx
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Vanderbilt-Ingram Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 2006
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (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 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 laboratory study is looking at DNA in tissue samples from patients with head and neck cancer.
Detailed description
OBJECTIVES:
- Assess common genetic mutations in tumor and germline DNA samples from patients with head and neck squamous cell carcinoma (HNSCC).
- Search for viral DNAs and relate this information to demographics, tumor characteristics, and patient prognosis.
- Search for novel viral sequences and cancer-associated gene mutations in young nonsmoking HNSCC patients and in other distinct head and neck cancers.
- Determine tumor suppressor gene mutations in HNSCC patients and relate this information to gene expression data.
- Validate gene expression information using independent techniques such as real-time PCR on expressed sequences and immunohistochemistry.
OUTLINE: Genetic mutation analysis and gene expression studies are performed on tissue samples from patients with head and neck squamous cell carcinoma. Techniques used include real time-PCR and immunohistochemistry.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Nonsmoking patients less than 40 years of age at first diagnosis of HNSCC.
Key inclusion criteria (3 listed)
- Patient with head and neck squamous cell carcinoma (HNSCC) enrolled in the Head and Neck Tissue Repository
- Historical material available from excess tissues at the Vanderbilt Pathology Department
Key exclusion criteria (3 listed)
- Not specified
- Not specified
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 |
|---|---|---|
| cytogenetic analysis | Genetic | – |
| gene expression analysis | Genetic | – |
| mutation analysis | Genetic | – |
| polymerase chain reaction | Genetic | – |
| immunohistochemistry staining method | Other | – |
| laboratory biomarker analysis | Other | – |
Primary outcome
Assess common genetic mutations in tumor and germline DNA samples
Time frame: Upon collection of final patient data
Viral DNAs related to demographics, tumor characteristics, and patient prognosis
Time frame: Upon collection of final patient data
Novel viral sequences and cancer-associated gene mutations in young nonsmoking patients with head and neck squamous cell carcinoma and in other distinct head and neck cancers
Time frame: Upon collection of final patient data
Tumor suppressor gene mutations related to gene expression data
Time frame: upon collection of final patient data
Validation of gene expression information using independent techniques such as real-time PCR on expressed sequences and immunohistochemistry
Time frame: upon collection of final patient data
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Cancer, run by Vanderbilt-Ingram Cancer Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, 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.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Assess common genetic mutations in tumor and germline DNA samples (time frame: Upon collection of final patient data). The study lists 5 primary outcomes in all. 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.