Head and Neck CancerNCT00899340
Protein Expression in Tumor Tissue Samples From Patients With Cancer of the Oropharynx
An observational study of Head and Neck Cancer, run by Vanderbilt-Ingram Cancer Center.
Trial summary
RATIONALE: Studying the proteins expressed in samples of tumor tissue from patients with cancer may help doctors identify and learn more about biomarkers related to cancer. It may also help doctors plan better treatment for patients with cancer of the oropharynx. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- gene expression analysis, microarray analysis and protein expression analysis
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- May 2006to Mar 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: community sample
Who may be able to join
- Diagnosis of squamous cell carcinoma of the oropharynx
- Tumor tissue samples available from Vanderbilt Head and Neck Tumor Repository and Vanderbilt Pathology archives
Who cannot join
- Not specified
- PRIOR CONCURRENT THERAPY:
- Not specified
About this study
Official title: Protein Expression Profiles in Oropharyngeal Squamous Cell Carcinoma
RATIONALE: Studying the proteins expressed in samples of tumor tissue from patients with cancer may help doctors identify and learn more about biomarkers related to cancer. It may also help doctors plan better treatment for patients with cancer of the oropharynx.
PURPOSE: This laboratory study is looking at protein expression in tumor tissue samples from patients with cancer of the oropharynx.
Read the detailed description
OBJECTIVES:
- To investigate if some of the differences in gene expression are also reflected at the protein level.
- To determine whether differences in gene expression that are also reflected at the protein level can be used to develop markers for early detection and disease surveillance.
- To identify targets for therapy.
OUTLINE: Archived tumor tissue samples are analyzed for expression of standard immunohistological markers (e.g., p16, p53, and Ki-67) as well as expression of genes identified in a previous gene expression study. Protein expression data are tested for clinical and demographic correlates and compared with gene expression data.
- Conditions
- Head and Neck Cancer
- Being tested
- gene expression analysis, microarray analysis, protein expression analysis, immunohistochemistry staining method, laboratory biomarker analysis
- Keywords
- recurrent squamous cell carcinoma of the oropharynx, stage I squamous cell carcinoma of the oropharynx, stage II squamous cell carcinoma of the oropharynx, stage III squamous cell carcinoma of the oropharynx, stage IV squamous cell carcinoma of the oropharynx
- Medical subject headings
- Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gene expression analysisGenetic
profiles of HPV(+) and (-) HNSCCs
microarray analysisGenetic
Also called SAM - significance Analysis of microarrays
microarray analysis
protein expression analysisGenetic
protein expression analysis
immunohistochemistry staining methodOther
immunohistochemistry staining method
laboratory biomarker analysisOther
laboratory biomarker analysis
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of biomarkers for early detection or recurrence surveillance
Measured: after 7 months of tissue collection
Identification of therapeutic targets and individualization of treatment based on the biology of squamous cell carcinoma of the oropharynx
Measured: after 7months of 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 startMay 2006
- Primary completionMar 2008
- Study completionMar 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
- Retrospective
- Enrolment
- 54 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
- NCT00899340
- Sponsor's protocol ID
- VICC HN 0624
- Other IDs
- VU-VICC-HN-0624, VU-VICC-IRB-060380
- 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
- Protein Expression Profiles in Oropharyngeal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT00899340
- Acronym / sponsor ID
- VICC HN 0624
- Conditions
- Head and Neck Cancer
- Keywords
- recurrent squamous cell carcinoma of the oropharynx, stage I squamous cell carcinoma of the oropharynx, stage II squamous cell carcinoma of the oropharynx, stage III squamous cell carcinoma of the oropharynx, stage IV squamous cell carcinoma of the oropharynx
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Vanderbilt-Ingram Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 2006
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 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 the proteins expressed in samples of tumor tissue from patients with cancer may help doctors identify and learn more about biomarkers related to cancer. It may also help doctors plan better treatment for patients with cancer of the oropharynx.
PURPOSE: This laboratory study is looking at protein expression in tumor tissue samples from patients with cancer of the oropharynx.
Detailed description
OBJECTIVES:
- To investigate if some of the differences in gene expression are also reflected at the protein level.
- To determine whether differences in gene expression that are also reflected at the protein level can be used to develop markers for early detection and disease surveillance.
- To identify targets for therapy.
OUTLINE: Archived tumor tissue samples are analyzed for expression of standard immunohistological markers (e.g., p16, p53, and Ki-67) as well as expression of genes identified in a previous gene expression study. Protein expression data are tested for clinical and demographic correlates and compared with gene expression data.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- community sample
Key inclusion criteria (2 listed)
- Diagnosis of squamous cell carcinoma of the oropharynx
- Tumor tissue samples available from Vanderbilt Head and Neck Tumor Repository and Vanderbilt Pathology archives
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 |
|---|---|---|
| gene expression analysisprofiles of HPV(+) and (-) HNSCCs | Genetic | – |
| microarray analysisAlso: SAM - significance Analysis of microarraysmicroarray analysis | Genetic | – |
| protein expression analysisprotein expression analysis | Genetic | – |
| immunohistochemistry staining methodimmunohistochemistry staining method | Other | – |
| laboratory biomarker analysislaboratory biomarker analysis | Other | – |
Primary outcome
Development of biomarkers for early detection or recurrence surveillance
Time frame: after 7 months of tissue collection
Identification of therapeutic targets and individualization of treatment based on the biology of squamous cell carcinoma of the oropharynx
Time frame: after 7months of tissue collection
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 2 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?
Development of biomarkers for early detection or recurrence surveillance (time frame: after 7 months of tissue collection). The study lists 2 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.