Head and Neck CancerNCT00896948
Study of Proteins in Head and Neck Cancer Cells
An observational study of Head and Neck Cancer, run by Vanderbilt University Medical Center at 3 sites in United States.
Trial summary
RATIONALE: Studying proteins in head and neck cancer cells 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 proteins in head and neck cancer cells. Read more about this study
- Who is it for?
- Ages Up to 120 years
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Southern blotting, TdT-mediated dUTP nick end labeling assay and gene expression analysis
- How many people
- Not given
- Where
- 3 sitesUnited States
- Study dates
- May 2005to not given
- 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 Up to 120 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Head and neck cancer tumor cell line
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- Not specified
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: Novel Protein Regulator of Tumor Suppressor ARF & NF-κB
RATIONALE: Studying proteins in head and neck cancer cells 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 proteins in head and neck cancer cells.
Read the detailed description
OBJECTIVES:
- Define the function and mechanism of LZAP in regulating ARF.
- Determine the mechanism and biological consequences of LZAP inhibition of NF-κB.
- Determine if LZAP has tumor suppressor activity by conditional targeting of LZAP in mice.
OUTLINE: Using molecular laboratory techniques, this study examines the biochemical mechanisms by which LZAP activates transcriptional, tumor suppressive activity (both p53-dependent and p53-independent) of ARF and inhibits transcriptional, tumorigenic activity of NF-kB. LZAP regulation of newly identified ARF activities, such as S-phase delay and ARF-mediated B23 degradation are also evaluated. LZAP's tumor suppressive activity is assessed in vivo using a conditional knockout vector to target LZAP in mice and to observe for spontaneous and induced tumor formation. Laboratory analyses used to determine study endpoints include standard recombinant DNA, recombinant protein expression and purification, cell culture and transfection, cell labeling, reporter assays, flow cytometry, yeast-two hybrid, immunoprecipitation, immunoblotting, immunofluorescence, TUNEL assay, ELISA assay, Southern blotting, and protein and gene expression.
- Conditions
- Head and Neck Cancer
- Being tested
- Southern blotting, TdT-mediated dUTP nick end labeling assay, gene expression analysis, protein expression analysis, flow cytometry
- Keywords
- head and neck cancer
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Southern blottingGenetic
TdT-mediated dUTP nick end labeling assayGenetic
gene expression analysisGenetic
protein expression analysisGenetic
flow cytometryOther
fluorescent antibody techniqueOther
immunoenzyme techniqueOther
immunologic techniqueOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Function and mechanism of LZAP in regulating ARF
Mechanism and biological consequences of LZAP inhibition of NF-κB
Determination of LZAP tumor suppressor activity
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 2005
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.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- 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
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Wendell G. Yarbrough, MD, FACS, Study chair, Vanderbilt-Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00896948
- Sponsor's protocol ID
- CDR0000558974
- Other IDs
- P30CA068485, VU-VICC-HN-0529, VU-VICC-IRB-050259
- Status last verified
- Mar 2017
- First submitted
- 9 May 2009
- Last updated
- 14 Mar 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Protein Regulator of Tumor Suppressor ARF & NF-κB
- ClinicalTrials.gov ID
- NCT00896948
- Acronym / sponsor ID
- CDR0000558974
- Conditions
- Head and Neck Cancer
- Keywords
- head and neck cancer
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 2005
- 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 proteins in head and neck cancer cells 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 proteins in head and neck cancer cells.
Detailed description
OBJECTIVES:
- Define the function and mechanism of LZAP in regulating ARF.
- Determine the mechanism and biological consequences of LZAP inhibition of NF-κB.
- Determine if LZAP has tumor suppressor activity by conditional targeting of LZAP in mice.
OUTLINE: Using molecular laboratory techniques, this study examines the biochemical mechanisms by which LZAP activates transcriptional, tumor suppressive activity (both p53-dependent and p53-independent) of ARF and inhibits transcriptional, tumorigenic activity of NF-kB. LZAP regulation of newly identified ARF activities, such as S-phase delay and ARF-mediated B23 degradation are also evaluated. LZAP's tumor suppressive activity is assessed in vivo using a conditional knockout vector to target LZAP in mice and to observe for spontaneous and induced tumor formation. Laboratory analyses used to determine study endpoints include standard recombinant DNA, recombinant protein expression and purification, cell culture and transfection, cell labeling, reporter assays, flow cytometry, yeast-two hybrid, immunoprecipitation, immunoblotting, immunofluorescence, TUNEL assay, ELISA assay, Southern blotting, and protein and gene expression.
Study design
Who may qualify
- Ages
- Up to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| Southern blotting | Genetic | – |
| TdT-mediated dUTP nick end labeling assay | Genetic | – |
| gene expression analysis | Genetic | – |
| protein expression analysis | Genetic | – |
| flow cytometry | Other | – |
| fluorescent antibody technique | Other | – |
| immunoenzyme technique | Other | – |
| immunohistochemistry staining method | Other | – |
| immunologic technique | Other | – |
Primary outcome
Function and mechanism of LZAP in regulating ARF
Mechanism and biological consequences of LZAP inhibition of NF-κB
Determination of LZAP tumor suppressor activity
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 14 Mar 2017.
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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.
Wendell G. Yarbrough, MD, FACS 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 University Medical Center at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 14 Mar 2017. 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 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?
Function and mechanism of LZAP in regulating ARF. The study lists 3 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 14 Mar 2017.